Mr. David McGraw
MS 90-1140
1 Cyclotron Road
Berkeley, CA 94720-
Phone: 510-486-5551
Fax: 510-486-7488
E-mail: dcmcgraw@lbl.gov
Number of Human Subjects projects reported: 35
| LBNL-75-001-H02 | "Experimental Medicine Clinical" |
| LBNL-77-057-H02 | "Studies of Lipoproteins and Lipid Protein Interactions" |
| LBNL-79-106-H02 | "Lipoproteins and Atherogenesis in Transgenic Animals" |
| LBNL-79-108-H01 | "Characterization of Human Mammary Cells" |
| LBNL-80-001-H01 | "Myocardial Flow, Function, and Metabolism by PET & MRI " |
| LBNL-84-001-H03 | "Alzheimer's Disease as a Systemic Disorder" |
| LBNL-90-068-H01 | "Red Cell Deformability In Vitro and Survival In Vivo" |
| LBNL-91-068-H03 | "Red Cell Membrane" |
| LBNL-91-107-H01 | "National Runners and Walkers Health Study" |
| LBNL-92-068-H02 | "Rheological and Adherence Properties of Sickle Cells" |
| LBNL-92-106-H04 | "Genes Affecting Metabolic Responses to Dietary Fat and Carbohydrates (formerly, Genetic and Metabolic Factors Affecting Response of Lp(a) to Dietary Fat) " |
| LBNL-92-107-H05 | "Effects of Running on HDL and LDL Subclasses of MZ Twins" |
| LBNL-94-093-H01 | "Modulation of Oxidant Stress-Mediated Atherosclerosis " |
| LBNL-97-001-H05 | "122-I Generator and Radiotracers for Perfusion Studies" |
| LBNL-98-106-H06 | "Genetic Testing for Evaluation of Heart Disease Risk" |
| LBNL-98-107-H06 | "National Health Survey on the Internet" |
| LBNL-98-139-H01 | "Breast Cancer Specific PET Instrumentation" |
| LBNL-99-107-H07 | "Effects of Genes on the Relationship of Lifestyle to Disease" |
| LBNL-99-133-H02 | "Development of Improved Methods for the Detection of Sensitivity to Beryllium in Human Beings and the Identification of Immunologic and Genetic Factors Which Determine this Sensitivity" |
| LBNL-00-005-H01 | "Training in Mammary Gland Biology and Breast Cancer" |
| LBNL-00-106-H09 | "Arterial Endothelial Function: An Epidemiological Study" |
| LBNL-00-166-H01 | "Control Study for Iodine-125 Thyroid In Vivo Analysis" |
| LBNL-01-063-H01 | "Estrogen Receptors in the Brain" |
| LBNL-01-106-H13 | "Comparative Genomic Analysis of Cardiovascular Gene Regulation" |
| LBNL-01-109-H02 | "Indoor Bioaerosol Detection and Quantification by Polymerase Chain Reaction (PCR)" |
| LBNL-01-166-H02 | "Study of Tritium in Subjects Near the National Tritium Labeling Facility" |
| LBNL-01-179-H01 | "Fast Identification of Lipoprotein Particles" |
| LBNL-01-180-H01 | "The Normal Magnetocardiogram (MCG): Spectrum of Findings with Rest and Exercise" |
| LBNL-02-106-H15 | "Pharmacogenetic Network for Cardiovascular Risk Therapy" |
| LBNL-02-106-H16 | "Dairy Research Institute for Genetics and Nutrition" |
| LBNL-02-107-H08 | "Validating Dietary Assessment on the Internet" |
| LBNL-02-109-H03 | "Task Ventilation Optimization" |
| LBNL-02-180-H02 | "A Pilot Study of the Magnetocardiogram (MCG) of Cardiac Patients with Angina Pectoris and Known Heart Disease" |
| LBNL-02-185-H01 | "Breast Cancer and Environmental Risk Factors in Marin County - Pilot Study Phase I and Phase II" |
| LBNL-02-186-H01 | "Chelation Therapy Using Calcium DTPA and/or Zinc DTPA for Internal Contamination with Plutonium and Other Transuranic Elements" |
"Experimental Medicine Clinical"
Principal Investigator: Dr. Thomas F. Budinger, Lawrence Berkeley National Laboratory
Project started in: 1975
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 13
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 11/26/01
IRB approval number: 2001-10-51
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: PET Study of Breast Cancer
OBJECTIVES
To evaluate the efficacy of the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality in detecting the presence and size of primary and metastatic breast cancer. The LBNL procedures are to be applied twice, once during the initial visit, then two to four months following this initial scan. The subject may benefit from the detection of the presence of metastasis. Society may benefit from an improved technique for the diagnosis and management of future breast cancer patients.
METHODOLOGY
A catheter will be placed in a vein in one arm to inject the radiotracer. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last as long as 120 minutes. A second scan will be performed two to four months following the initial scan to evaluate progression of the disease for subjects off therapy or therapeutic response for subjects who are receiving therapy.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Fluorine-18 Fluorodeoxyglucose (FDG-18)
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and/or MRI are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 12/14/01
IRB approval number: 2001-10-52
Explanation of IRB approval:
Protocol was under review at the end of the fiscal year and was only renewed just after the fiscal year began.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
OBJECTIVES
To evaluate the efficacy of the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality in detecting the viability of the heart muscle. The current trial is aimed at determining which of the patients with a negative diagnosis by a thallium perfusion study have a positive diagnosis for reversible disease by FDG. The benefit of this study to the subject and future individuals with damaged heart muscle is reversibility.
METHODOLOGY
Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm to inject the radiotracer. After a half-hour uptake phase, subjects are asked to empty their bladder to keep the radiation exposure to the bladder as low as possible. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last as long as 120 minutes.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Fluorine-18 Fluorodeoxyglucose.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risks include: venous catheter (bruising, faintness); radiation (equivalent to a back x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and/or MRI are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 08/25/00
IRB approval number: 2000-8-118
Explanation of IRB approval:
Approval of this protocol was pending submission of a major modification by the researcher. It was withdrawn in February, 2002.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 08/25/00 to 08/24/01
Explanation:
Period between the last IRB review and approval and expiration of the protocol's approval.
Type(s) of Human Subjects Involvement:
TITLE: Coronary Artery Disease Evaluation by Quantitative Perfusion Studies Using 13NH3 and PET
OBJECTIVES
The purpose of this project is to develop noninvasive, rapid, and economical methods for the evaluation of cardiac ischemia. This protocol will evaluate the clinical utility of quantitative heart perfusion data obtained with the radiotracer 13-nitrogen ammonia (13NH3) and Positron Emission Tomography (PET). The PET scan may provide information that could benefit the patient in his/her overall therapy management, but such a benefit is not assured. Society would benefit from improved and more economical diagnostic tests.
METHODOLOGY
A catheter will be placed in a vein in one arm to inject the radiotracers and to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. A blood glucose test will be performed, and patients with blood sugars less that 120 mg% will receive oral glucose loading. After positioning the subject in the PET scanner, a transmission scan without radiotracer will be done to allow corrections of the emission data. Next the first 35 mCi dose of 13NH3 is injected and a resting PET scan is taken. Between 30 and 40 minutes after the initial tracer injection, dipyridamole will be infused intravenously. The second 13NH3 injection is given about 4 minutes after the perfusion is completed and the final PET scan begins shortly thereafter. Subjects may not move during the scans. The total procedure should take about 120 minutes.
RADIATION/CHEMICAL SUBSTANCES
13-nitrogen ammonia; dipyridamole
INVOLVEMENT OF HUMAN SUBJECTS
Risks include: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray); and the routine risks associated with any clinical use of dipyridamole (occasional severe chest pain, severe hypotension, respiratory distress, and vomiting or nausea; rarely, symptoms of myocardial ischemia requiring the use of aminophylline to reverse the effect; very rarely, heart attack or death).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET scans are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
RENEWAL OF THIS PROTOCOL IS PENDING A MAJOR REVISION BY THE RESEARCHER. NO SUBJECTS WILL BE STUDIED UNDER THE PROTOCOL UNTIL IT IS AGAIN FULLY APPROVED BY THE INSTITUTIONAL REVIEW BOARD.
THIS PROTOCOL WAS FORMALLY WITHDRAWN IN FEBRUARY, 2002.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/14/01
IRB approval number: 2001-3-51
Explanation of IRB approval:
Study was discontinued February 22, 2002.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 04/14/01 to 02/22/02
Explanation:
Study was discontinued February 22, 2002.
Type(s) of Human Subjects Involvement:
TITLE: Cardiovascular Relationships in Alzheimer's Disease --Determination of Peripheral Vascular Reactivity
OBJECTIVES
The goal of this study is to demonstrate the presence or absence of strong correlations between Alzheimer's disease (AD) and peripheral cardiovascular disease. Societal benefits may include a greater understanding of dementing illnesses.
METHODOLOGY
An equal number of control subjects and AD patients will be recruited. Patient subjects are accompanied by an adult family member or guardian to assure an appropriate consent process. AD patients will have been previously evaluated by their treating clinic and these results will be made available to the researchers.
On the day of the study, a small sample of venous blood will be drawn for lipoprotein analysis in order to correlate LDL levels, reactivity and subject illness. Vascular reactivity to the tightening and releasing of a blood pressure cuff will then be non-invasively measured using a Food and Drug Administration approved Doppler flow system.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
None
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include: venous catheter (bruising, faintness), discomfort due to the squeezing of the blood pressure cuff.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. The results from the venous blood analysis are supplied to the patients' personal physicians upon request. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena. In patients whose cognition is or may be impaired, the consent of the responsible next of kin or conservator as well as the assent of the patient will be sought.
NOTE: The number of subjects participating under this protocol is reported under "Alzheimer's Disease as a Systemic Disorder" (LBNL-84-001-H03).
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 09/20/02
IRB approval number: 2002-4-82
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 09/20/02 to 09/30/02
Explanation:
Initial period of approval falling within fiscal year 2002.
Type(s) of Human Subjects Involvement:
TITLE: "Assessment of Maximum Vasiodilatory Reserve and Sensitivity to Ischemia"
OBJECTIVES
The purpose of this study is to evaluate a measure of vasodilatory reserve and sensitivity to ischemia. The method will be evaluated before and after consumption of nicotine or meals of varying composition.
METHODOLOGY
Up to forty male and female subjects will be recruited by posting advertisements in local newspapers. Half will be assigned to Group 1 (nicotine study) and half to Group 2 (diet study). Subjects with heart disease, vascular conditions, clotting disorders, hypertension, or a recent venipuncture will be excluded. Both groups will fast for twelve hours pre-study. Subjects in Group 1 will participate up to ten times, and subjects in Group 2 five times.
Core Procedure: The subject's arm will be positioned in a frame. An artificial pulse will be created by using a mechanical device to gently tap the arm throughout the procedure. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 - 220 mmHg (slightly tighter than used for normal blood pressure measurements) for 'O' seconds. The sound of the artificial pulse will be recorded before, during, and for 'M' minutes after the blood pressure cuff is released using a laser Doppler imager. The cuff will be tightened and released three times during each procedure; each cycle of tightening will be longer than the previous. The value of 'O' will vary from 15 to 300 seconds, and 'M' from 30 to 120 seconds.
Group 1: Subjects will fast for 12 hours before each study. On the day of the study, each subject will receive a brief medical screening. The subject will then have a set of measurements taken use the Core Procedure, will chew nicotine polacrilex gum for about thirty minutes, then have a second set of Core measurements. The dose of nicotine will be similar to or less than used for smoking cessation.
Group 2: Subjects will fast for 12 hours before each study. On the day of the study, each subject will receive a brief medical screening. The subject will then have a set of measurements taken use the Core Procedure, will eat a meal of known fat composition, and then undergo a second set of Core measurements. The meals will vary with each experiment, and will include low fat; high fat, low polyunsaturated fat; high fat, high polyunsaturated fat; etc..
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Nicotine gum;
Cream pudding prepared by a nutritionist to meet the fat composition goals of the study.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include the discomfort and the possibility of bruising from the blood pressure cuff and minor irritation from the electrode paste. Subjects are also informed that while the use of blood pressure cuffs to block blood supply to the arm has been shown to be safe for up to 30 minutes, that the repeated blocking of the blood supply for much shorter periods might conceivable pose some unanticipated risks.
Nicotine gum may cause a burning or tingling sensation in the mouth, nausea, raised blood pressure, heartburn, and headache.
PRIVACY/CONFIDENTIALITY/CONSENT
The identities of the subjects are known, but any public report is by code numbers only. The results of the tests are discussed with the subjects. Subjects are reminded that research records are not immune to subpoena.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 10/09/01
IRB approval number: 2001-10-71
Explanation of IRB approval:
This protocol expired in October 2001 and the investigators subsequently decided not to renew it.
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: University of California at San Francisco
Most recent approval: 08/02/01
IRB approval number: H5637-15422-04
Explanation of additional approval:
This protocol expired in August 2001 and the investigators subsequently decided not to renew it.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: PET Transmission Studies
OBJECTIVE
The goal of this project is to produce better quality Positron Emission Tomography (PET) images with higher resolution. The researchers will examine how PET technology and analysis algorithms can compensate for the slight movements made by the chest during normal breathing. Subjects will receive no direct benefit, but society may benefit from improved PET diagnostic techniques.
METHODOLOGY
Subjects will receive a single PET scan of 1 - 2 hours without catheterization or radiotracer.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: the discomfort of lying still for a prolonged period; radiation (equivalent to less than 1/20th of a back x-ray). Note that no radiotracer is given.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Subjects are reminded that research records are not immune to subpoena.
IN 1998, THE PERFORMANCE SITE OF THESE STUDIES CHANGED TO THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/05/02
IRB approval number: 2002-4-70
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 15
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Evaluation of Vascular Reactivity in Alzheimer's Disease via Iontophoresis of Vasoactive Compounds
OBJECTIVES
The goal of this study is to continue to examine the presence or absence of strong correlations between Alzheimer's disease (AD) and peripheral cardiovascular disease. Societal benefits may include a greater understanding of dementing illnesses.
METHODOLOGY
An equal number of control subjects and AD patients will be recruited. Patient subjects are accompanied by an adult family member or guardian to assure an appropriate consent process. AD patients will have been previously evaluated by their treating clinic and these results will be made available to the researchers.
Subjects will fast for 12 hours prior to their study. On the day of the study, subjects will be screened for factors such as the use of aspirin. A small sample of venous blood will be drawn for lipoprotein analysis in order to correlate LDL levels, reactivity and subject illness. A picture of the blood vessels in the hand will be taken using a laser scanner. The laser is similar in intensity to a laser pointer and is not damaging to the skin.
Areas of the skin will be cleaned using isopropyl alcohol. Small amounts of up to five vasodilators and/or constrictors will be dabbed onto the subject's skin. A one inch square electrode will be placed over the applied chemical, and a tiny electric current applied to cause the chemical to move into localized areas the skin and underlying capillaries. Changes in the circulation will then be non-invasively measured using the same non-invasive laser scanner described above.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
The vasodilators and/or constrictors which may be applied to localized areas of the skin of the arm are: sildenafil citrate; nitro-L-arginine methy ester; nitroprusside; methacholine; acetylcholine. None of the applications will result in a significant or even measurable systemic dose.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include: venous catheter (bruising, faintness); minor skin irritation or allergic reaction from the chemicals applied to the skin; a slight, transient tingling feeling from the iontophoresis electrode.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. The results from the venous blood analysis are supplied to the patients' personal physicians upon request. Subjects are reminded that research records are not immune to subpoena. In patients whose cognition is or may be impaired, the consent of the responsible next of kin or conservator as well as the assent of the patient will be sought.
NOTE: The number of subjects participating under this protocol is reported under "Alzheimer's Disease as a Systemic Disorder" (LBNL-84-001-H03). Additional subjects were not studied under this project, therefore, the number of subjects reported here is zero to prevent counting the same subjects twice.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 06/22/01
IRB approval number: 2001-6-149
Explanation of IRB approval:
This study has been discontinued, as of March 18, 2002.
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: University of California at San Francisco
Most recent approval: 04/19/01
IRB approval number: H5637-14948-04
Explanation of additional approval:
This study has been discontinued as of March 2002.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 06/22/01 to 03/18/02
Explanation:
Study was discontinued in March 2002.
Type(s) of Human Subjects Involvement:
TITLE: Coronary Artery Disease Evaluation by Quantitative Perfusion Studies Using Rest/Stress 62-Cu PTSM and Positron Emission Tomography (PET) vs. Rest/Stress 201 T1 or 99mTc - Sestamibi Single Photon Emission Computed Tomography (SPECT)
OBJECTIVES
The purpose of this project is to develop noninvasive, rapid, and economical methods for the evaluation of cardiac ischemia. This protocol will compare the clinical utility of quantitative heart perfusion data obtained with the radiotracer 62-copper pyruvaldehyde Bis (N(4)-methyl) thiosemicarbazone (62-Cu PTSM) and PET scanning to SPECT scans done with Food and Drug Administration approved perfusion tracers.
The PET scan may provide information that could benefit the patient in his/her overall therapy management, but such a benefit is not assured. Society would benefit from improved and more economical diagnostic tests.
METHODOLOGY
Subjects with suspected stable ischemic coronary artery disease who either have undergone or are scheduled to undergo coronary angiography and a SPECT myocardial perfusion study will be recruited for this protocol. Neither the angiography nor the SPECT scan will be performed as part of this study.
For the PET scan, a catheter will be placed in a vein in one arm to inject the radiotracers and to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. After positioning the subject in the PET scanner, a transmission scan without radiotracer will be done to allow corrections of the emission data. Next the first 30 mCi dose of 62-Cu PTSM is injected and a resting PET scan is taken. Between 40 and 50 minutes after the initial tracer injection, hypotension will be induced by adenosine or dipyridamole injection or by cold pressor stimulation (immersion of a hand in ice water). The second 62-Cu PTSM injection is given about 4 minutes after the infusion of adenosine or dipyridamole (or 30 seconds after cold pressor stimulation) is completed and the final PET scan begins shortly thereafter. Subjects may not move during the scans. The effect of dipyridamole will be reversed by the use of aminophylline; the effect of cold pressor stimulation by the use of nitroglycerine if needed. The total procedure should take about 120 minutes.
RADIATION/CHEMICAL SUBSTANCES
62-Cu PTSM; adenosine or dipyridamole and aminophylline or possibly nitroglycerine
INVOLVEMENT OF HUMAN SUBJECTS
Risks include: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray); the routine risks associated with any clinical use of adenosine, dipyridamole or cold pressor stimulation (occasional severe chest pain, severe hypotension, respiratory distress, and vomiting or nausea; rarely, symptoms of myocardial ischemia requiring the use of aminophylline to reverse the effect; very rarely, heart attack or death), and the discomfort associated with lying still for an extended period of time.
Most subjects will receive only one PET scan. Up to five subjects will receive a second 62-Cu PTSM PET study.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET scans are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
THE SITE AT WHICH THESE PET STUDIES TAKE PLACE CHANGED TO THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, IN MAY, 1999.
This study has been discontinued.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 05/24/01
IRB approval number: 2001-1-36
Explanation of IRB approval:
Protocol was discontinued in March, 2002.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 05/24/01 to 03/13/02
Explanation:
Period during which protocol had approval
Type(s) of Human Subjects Involvement:
TITLE: Ultrasound Assessment of the Effect of a Fatty Meal on Vascular and Hemodynamic Properties
OBJECTIVES
The objective of the study is to measure the hemodynamic and oxidative effects of a fatty meal on endothelial function and blood flow. Blood flow and arterial wall motion will be measured with an ultrasound device before and after meals with varying amounts of fat.
METHODOLOGY
Ten male and ten female subjects will be recruited by posting advertisements in local newspapers. Subjects with heart disease will be excluded. Each subject will be examined on nine separate occasions, before and after consuming three different meals (high fat high in saturated fat, high fat low in saturated fat, and low fat). The blood flow determination will be made with an experimental ultrasound device.
On the day of each study, subjects will be asked to fast. Upon arrival, their blood pressure and an initial sample of blood (1 tablespoon) will be taken. The blood will be analyzed for lipids, fatty acids, insulin and glucose levels, and blood viscosity. A hand-held ultrasound device will be put on the wrist, upper arm, or the bottom of the neck to take blood flow measurements.
Subjects will then consume a prepared meal of approximately one cup in volume. Additional blood samples will be drawn one and two hours post prandial, followed by an ultrasound assessment.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Cream pudding formulated under the direction of a nutritional scientist to meet the fat composition goals of the study.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include: the risks common to a routine blood draw (bruising, faintness, and the slight chance of infection).
The Institutional Review Board found the ultrasound device to qualify for a non-significant risk Investigational Device Exemption.
PRIVACY/CONFIDENTIALITY/CONSENT
The identities of the subjects are known, but any public report is by code numbers only. The results from the venous blood analysis are supplied to the subjects upon request. Subjects are reminded that research records are not immune to subpoena, and are subject to review by the Food and Drug Administration.
THIS PROTOCOL WAS DISCONTINED IN MARCH, 2002.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 01/11/02
IRB approval number: 2002-1-74
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 3
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Evaluation of a New Instrument for the Assessment of Vascular Function
OBJECTIVES
The purpose of this study is to compare how well two different devices measure blood flow in the arteries of the arm. The goal is to produce a small, low cost device that could be used as part of a routine medical check-up to evaluate arterial health.
METHODOLOGY
Up to thirty male and female subjects will be recruited by posting advertisements in local newspapers. Subjects with heart disease, vascular conditions, clotting disorders, hypertension, or a recent venipuncture will be excluded. Each subject will be examined with both the relaxoscope (Device A, the test device) and B-mode/M-mode procedure (Device B, the current standard).
On the day of the study, each subject will receive a brief medical screening. The first 15 subjects will be tested with Device B first, and the second 15 with Device A first. After completion of the first test, subjects will wait about an hour and then be tested with the second device.
Device A procedure: The subject's arm will be positioned in a frame. An artificial pulse will be created by using a mechanical device to gently tap the arm throughout the procedure. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 - 220 mmHg (slightly tighter than used for normal blood pressure measurements) for 4-6 minutes. The sound of the artificial pulse will be recorded before, during, and for ten minutes after the blood pressure cuff is released using a Doppler stethoscope.
Device B procedure (the current standard): The subject's arm will be positioned in a different frame. EKG electrodes will be attached. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 - 220 mmHg (slightly tighter than used for normal blood pressure measurements) for about 4 minutes. Variation of the arterial diameter will be measured before, during and after release of the blood pressure cuff.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include:
Device A --Discomfort and the possibility of bruising from the blood pressure cuff; possibility of minor bruising from the tapping device or the frame.
Device B --Discomfort and the possibility of bruising from the blood pressure cuff and minor irritation from the electrode paste.
PRIVACY/CONFIDENTIALITY/CONSENT
The identities of the subjects are known, but any public report is by code numbers only. The results of the tests are discussed with the subjects. Subjects are reminded that research records are not immune to subpoena, and are subject to review by the Food and Drug Administration.
Because of the discomfort associated with wearing a blood pressure cuff tightened over 200 mmHg for 4 to 6 minutes, subjects are specifically reminded that they can ask to have the cuff removed at any time.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 02/19/02
IRB approval number: 2002-2-93
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 4
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: The Study of breast Cancer Using C-11 Choline and Positron Emission Tomography
OBJECTIVES
To evaluate the biokinetics of C-11 choline with a view towards its usefulness as a radiotracer for the identification of breast cancer by positron emission tomography (PET). Choline is expected to be preferentially picked up by the tumor because of a known increase in choline kinase in malignant cells as compared to normal tissue.
METHODOLOGY
Up to thirty subjects with breast cancer confirmed through other diagnostic procedures will be recruited through contact with primary care physicians. Results from this scan will be correlated with other imaging modalities (magnetic resonance imaging, ultrasound, etc.) that are given to the subject as part of their clinical care.
Prior to the scan, a short medical history of the current disease and an accounting of food consumption during the prior 48 hours will be taken.
A catheter will be placed in a vein in one arm to inject the radiotracer. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last as long as 120 minutes. A second scan will be performed two to twelve months following the initial scan to evaluate changes in biokinetics associated with the subject's status and to determine if the kinetics of tumor uptake corresponds to that expected from other measures of cancer progression or regression.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Carbon-11 Choline. This is a Radioactive Drug Research Committee monitored protocol.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 02/19/02
IRB approval number: 2002-2-94
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: The Study of Prostate Cancer Using C-11 Choline and Positron Emission Tomography
OBJECTIVES
To evaluate the biokinetics of Carbon-11 choline with a view towards its usefulness as a radiotracer for the identification of prostate cancer and its metastasis in positron emission tomography (PET). Choline is expected to be preferentially picked up by the tumor because of a known increase in choline kinase in malignant cells as compared to normal tissue. Choline may also be a better candidate for prostate imaging as it is not expected to collect in the bladder.
METHODOLOGY
Up to thirty subjects with prostate cancer confirmed through other diagnostic procedures will be recruited through contact with primary care physicians. Results from this scan will be correlated with other imaging modalities (magnetic resonance imaging, ultrasound, etc.) that are given to the subject as part of their clinical care.
Prior to the scan, a short medical history of the current disease and an accounting of food consumption during the prior 48 hours will be taken.
A catheter will be placed in a vein in one arm to inject the radiotracer. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last as long as 120 minutes. A second scan will be performed two to twelve months following the initial scan to evaluate changes in biokinetics associated with the subject's status and to determine if the kinetics of tumor uptake corresponds to that expected from other measures of cancer progression or regression.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Carbon-11 Choline. This is a Radioactive Drug Research Committee monitored protocol.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 09/20/02
IRB approval number: 2002-4-83
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 09/20/02 to 09/30/02
Explanation:
Initial period of approval falling within fiscal year.
Type(s) of Human Subjects Involvement:
TITLE: Assessment of the Effect of Meal Composition on Vascular Function
OBJECTIVES
The purpose of this study is to study the effects of dietary fat on the short-term function of blood vessels. The researchers will also be testing a new device which measures these effects.
METHODOLOGY
Up to thirty male and female subjects between 21 and 48 years of age will be recruited by posting advertisements in local newspapers. Subjects with heart disease, vascular conditions, clotting disorders, hypertension, or a recent venipuncture will be excluded. Subjects will be asked to participate on 5 separate occasions.
Subjects will be asked to abstain from use of anti-inflammatory drugs for two days before each experiment, and to fast and abstain from the use of products known to affect circulation (i.e., cigarettes, weight-loss medications) for 12 hours before. On the day of the experiment, each subject will receive a brief medical screening. Each experiment will consist of a baseline blood sample, a set of baseline readings using both Device A and Device B, followed by consumption of a meal of known fat content, and then a second set of measurements and a second blood sample. The fat and carbohydrate content of the meal will vary for each experiment.
Device A procedure: The subject's arm will be positioned in a frame. An artificial pulse will be created by using a mechanical device to gently tap the arm throughout the procedure. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 - 220 mmHg (slightly tighter than used for normal blood pressure measurements) for 4-6 minutes. The sound of the artificial pulse will be recorded before, during, and for ten minutes after the blood pressure cuff is released using a Doppler stethoscope.
Device B procedure (the current standard): The subject's arm will be positioned in a different frame. EKG electrodes will be attached to the hands and right foot. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 - 220 mmHg (slightly tighter than used for normal blood pressure measurements) for about 4 minutes. Variation of the arterial diameter will be measured before, during and after release of the blood pressure cuff.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Cream pudding prepared by a nutritionist to meet the fat composition goals of the study.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include:
Those common to venipuncture --Bruising, slight risk of infection.
Device A --Discomfort and the possibility of bruising from the blood pressure cuff; possibility of minor bruising from the tapping device or the frame.
Device B --Discomfort and the possibility of bruising from the blood pressure cuff and minor irritation from the electrode paste.
PRIVACY/CONFIDENTIALITY/CONSENT
The identities of the subjects are known, but any public report is by code numbers only. The results of the tests are discussed with the subjects. Subjects are reminded that research records are not immune to subpoena, and are subject to review by the Food and Drug Administration.
Because of the discomfort associated with wearing a blood pressure cuff tightened over 200 mmHg for 4 to 6 minutes, subjects are specifically reminded that they can ask to have the cuff removed at any time.
"Studies of Lipoproteins and Lipid Protein Interactions"
Principal Investigator: Dr. Edward Rubin, Lawrence Berkeley National Laboratory
Project started in: 1977
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/16/02
IRB approval number: 2002-4-75
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
OBJECTIVES
Interdisciplinary training program in cellular, molecular, and biophysical aspects of lipid and lipoprotein metabolism and the process of atherogenesis.
METHODOLOGY
Trainees participate in research carried out under other approved protocols. In the past, trainees have utilized blood samples drawn under the protocol LBNL-79-106-H02 (Krauss, Ronald: "Metabolic & Genetic Origins of Lipoprotein Subclasses"). No other involvement with human subjects has been reported.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Human subjects involvement in the last few years has been limited to the use of surplus blood collected for another project. No additional risks to subjects are incurred as a result of this grant.
CONFIDENTIALITY
Confidentiality provisions are the same as those of the source protocol. Only samples collected under consent processes that inform subjects that their samples may be used in other research projects may be used by fellows under this training grant.
NO POST-DOCTORAL TRAINEES PARTICIPATED IN HUMAN SUBJECTS RESEARCH IN FISCAL YEAR 2002.
"Lipoproteins and Atherogenesis in Transgenic Animals"
Principal Investigator: Dr. Ronald M. Krauss, Lawrence Berkeley National Laboratory
Project started in: 1979
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 3
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 02/08/02
IRB approval number: 2002-2-64
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Blood Donations for Family Studies
OBJECTIVES
The objective of this study is to examine the inheritance of lipid and lipoprotein levels and the physical properties, as well as chemical composition, of human plasma proteins in order to obtain insights on how to control heart diseases.
METHODOLOGY
Up to 80cc of blood are drawn from subjects via venipuncture. Additionally, a medical interview is conducted with each subject in which demographic information, family/personal health history, dietary, exercise and smoking habits, etc., are requested.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
The risks are those common to venipuncture (bruising, slight risk of infection). Please note that the figure given for Number of Human Subjects, is the number of samples collected; some subjects may have given multiple samples.
CONFIDENTIALITY
Collection of samples is not anonymous. Subjects are informed that a portion of the blood will be stored for possible future analysis by collaborating investigators. Lipoprotein analysis results are supplied to the subject's personal physician only when requested by the subject.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/23/02
IRB approval number: 2002-2-53
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Blood Donations for Transgenic Studies
OBJECTIVES
The objective of this study is to produce mice that carry specific human transgenes. This will enable researchers to study the phenotypic effects of specific genes in an animal model.
METHODOLOGY
Subjects will be recruited from the "Blood Donations for Family Studies" protocol (MM2337). Up to 80cc of blood is drawn via venipuncture. Additionally, a medical interview is conducted with each subject in which demographic information, family/personal health history, dietary, exercise and smoking habits, etc., are requested. DNA will be obtained for the white blood cells and used as a source of transgenes.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
The risks are those common to venipuncture (bruising, slight risk of infection). Subjects are also informed that there is no plan for them to share in any income arising from the new transgenic mouse strains.
CONFIDENTIALITY
Collection of samples is not anonymous, but samples are supplied to the transgenic facility anonymously. The identity of the human gene donors will not be linked to the resultant mouse strains.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 02/08/02
IRB approval number: 2002-2-65
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 353
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Blood Donations for Lipoprotein Research
OBJECTIVES
The objective of this study is to obtain blood for isolation of lipoproteins and plasma proteins, and as a source of lipids for lipoprotein interaction studies. Since certain lipoproteins have been indicated as predisposing individuals to arteriosclerosis and heart disease, this study aims to obtain insights on how to control such diseases.
METHODOLOGY
Not more than a unit of blood (500cc) will be drawn from donors by venipuncture. Blood bank criteria will be used in determining the frequency of donor use. Some donors may be asked to fast overnight prior to blood withdrawal.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Risks are those common to venipuncture (bruising, mild risk of infection). Please note that the figure given for Number of Human Subjects, is the number of samples collected; some subjects may have given multiple samples.
CONFIDENTIALITY
Collection of samples is not anonymous. Subjects are informed that a portion of the blood will be stored for possible future analysis by collaborating investigators. Lipoprotein analysis results are supplied to the subject's personal physician only when requested by the subject.
"Characterization of Human Mammary Cells"
Principal Investigator: Dr. Martha R. Stampfer, Lawrence Berkeley National Laboratory
Project started in: 1979
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 06/23/01
IRB approval number: 2001-4-91
Explanation of IRB approval:
Renewal is pending.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
This research is concerned with the growth control of human breast cells and the relationship of differentiation with transformation.
Human milk contains a small number of living cells that have been sloughed off from the breast tissue during the secretory process. These sloughed cells are isolated from human milk samples and studied to gain an insight into the events taking place within the breast tissue.
Subjects are asked to provide information relating to their general health, age, race, and birth of their child. They express one or more samples of breast milk using their own equipment in the privacy of their home. As subjects are performing this process on a regular basis, no risk directly related to the research is anticipated.
These samples are not collected anonymously. However, when tissue samples or cell cultures are made available to other researchers they are identified only by code number. Subjects are informed as part of the consent process that their samples may be used by others.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 06/23/01
IRB approval number: 2001-4-91
Explanation of IRB approval:
Renewal is pending.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The investigator's goal is to determine the morphological, biological, and biochemical properties associated with normal, atypical, and malignant mammary epithelial cells. Such studies will elucidate mechanisms of human carcinogenesis and aid clinicians in the early detection of breast cancer.
The research will use portions of residual tissues from medical procedures such as aspiration of cysts, mammary biopsies, reduction mammoplasty, or mastectomy. Residual tissues from other sites (e.g., skin, cervix) may also be obtained. Samples are identified by patient number and donor location and may be accompanied by medical history data.
Collection of the samples poses no additional risk to the subject. Samples are only obtained from subjects who have given permission for the research use of their tissues.
These samples are not collected anonymously, but arrive at the Laboratory already identified by code number.
"Myocardial Flow, Function, and Metabolism by PET & MRI"
Principal Investigator: Dr. Thomas F. Budinger, Lawrence Berkeley National Laboratory
Project started in: 1980
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 5
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 01/11/02
IRB approval number: 2002-1-74
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
Abstract:
TITLE: Evaluation of New Instrument for the Assessment of Vascular Function
OBJECTIVES
The purpose of this study is to compare how well two different devices measure blood flow in the arteries of the arm. The goal is to produce a small, low cost device that could be used as part of a routine medical check-up to evaluate arterial health.
METHODOLOGY
Up to thirty male and female subjects will be recruited by posting advertisements in local newspapers. Subjects with heart disease, vascular conditions, clotting disorders, hypertension, or a recent venipuncture will be excluded. Each subject will be examined with both the relaxoscope (Device A, the test device) and B-mode/M-mode procedure (Device B, the current standard).
On the day of the study, each subject will receive a brief medical screening. The first 15 subjects will be tested with Device B first, and the second 15 with Device A first. After completion of the first test, subjects will wait about an hour and then be tested with the second device.
Device A procedure: The subject's arm will be positioned in a frame. An artificial pulse will be created by using a mechanical device to gently tap the arm throughout the procedure. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 - 220 mmHg (slightly tighter than used for normal blood pressure measurements) for 4-6 minutes. The sound of the artificial pulse will be recorded before, during, and for ten minutes after the blood pressure cuff is released using a Doppler stethoscope.
Device B procedure (the current standard): The subject's arm will be positioned in a different frame. EKG electrodes will be attached. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 - 220 mmHg (slightly tighter than used for normal blood pressure measurements) for about 4 minutes. Variation of the arterial diameter will be measured before, during and after release of the blood pressure cuff.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include:
Device A --Discomfort and the possibility of bruising from the blood pressure cuff; possibility of minor bruising from the tapping device or the frame.
Device B --Discomfort and the possibility of bruising from the blood pressure cuff and minor irritation from the electrode paste.
PRIVACY/CONFIDENTIALITY/CONSENT
The identities of the subjects are known, but any public report is by code numbers only. The results of the tests are discussed with the subjects. Subjects are reminded that research records are not immune to subpoena, and are subject to review by the Food and Drug Administration.
Because of the discomfort associated with wearing a blood pressure cuff tightened over 200 mmHg for 4 to 6 minutes, subjects are specifically reminded that they can ask to have the cuff removed at any time.
NOTE: The number of subjects participating under this protocol is reported under "Experimental Medicine Clinical" (LBNL 75-001-H02). Additional subjects were not studied under this project, therefore, the number of subjects reported here is zero to prevent counting the same subjects twice.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 08/25/00
IRB approval number: 2000-8-118
Explanation of IRB approval:
Approval of this protocol was pending submission of a major modification by the researcher. It was withdrawn in February, 2002.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 08/25/00 to 08/24/01
Explanation:
Period between the last IRB review and approval and expiration of the protocol.
Type(s) of Human Subjects Involvement:
TITLE: Coronary Artery Disease Evaluation by Quantitative Perfusion Studies Using 13NH3 and PET
OBJECTIVES
The purpose of this project is to develop noninvasive, rapid, and economical methods for the evaluation of cardiac ischemia. This protocol will evaluate the clinical utility of quantitative heart perfusion data obtained with the radiotracer 13-nitrogen ammonia (13NH3) and Positron Emission Tomography (PET).
The PET scan may provide information that could benefit the patient in his/her overall therapy management, but such a benefit is not assured. Society would benefit from improved and more economical diagnostic tests.
METHODOLOGY
A catheter will be placed in a vein in one arm to inject the radiotracers and to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. A blood glucose test will be performed, and patients with blood sugars less that 120 mg% will receive oral glucose loading. After positioning the subject in the PET scanner, a transmission scan without radiotracer will be done to allow corrections of the emission data. Next the first 35 mCi dose of 13NH3 is injected and a resting PET scan is taken. Between 30 and 40 minutes after the initial tracer injection, dipyridamole will be infused intravenously. The second 13NH3 injection is given about 4 minutes after the perfusion is completed and the final PET scan begins shortly thereafter. Subjects may not move during the scans. The total procedure should take about 120 minutes.
RADIATION/CHEMICAL SUBSTANCES
13-nitrogen ammonia; dipyridamole
INVOLVEMENT OF HUMAN SUBJECTS
Risks include: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray); and the routine risks associated with any clinical use of dipyridamole (occasional severe chest pain, severe hypotension, respiratory distress, and vomiting or nausea; rarely, symptoms of myocardial ischemia requiring the use of aminophylline to reverse the effect; very rarely, heart attack or death).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET scans are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
NOTE: The number of subjects participating under this protocol is reported under "Experimental Medicine Clinical" (LBNL 75-001-H02). Additional subjects were not studied under this project, therefore, the number of subjects reported here is zero to prevent counting the same subjects twice.
RENEWAL OF THIS PROTOCOL WAS PENDING A MAJOR REVISION BY THE RESEARCHER. IT WAS FORMALLY WITHDRAWN IN FEBRUARY, 2002.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 10/17/01
IRB approval number: 2001-10-72
Explanation of IRB approval:
This protocol is being discontinued.
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: University of California at San Francisco
Most recent approval: 08/23/01
IRB approval number: H5637-15423-04
Explanation of additional approval:
This protocol expired in August of 2001 at UCSF and the investigators have opted not to renew it.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 9
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Evaluation of the Benefits of Motion Compensation in Cardiac Positron Emission Tomography (PET) with Respiratory and Cardiac Gating
OBJECTIVES
The small movements of the chest caused by breathing and the beating of the heart currently degrades the quality of positron emission tomograph (PET)images. The purpose of this project is to evaluate the utility of motion compensation in cardiac PET studies. The individual subjects will be healthy volunteers and will not benefit from the research. Society would benefit from more accurate and economical diagnostic tests.
METHODOLOGY
Up to 20 healthy human volunteers will be sought through advertisement. Subjects will receive a standard PET scan, described below, with one or two rubber bellows placed around the torso to monitor breathing movement.
Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm to inject the radiotracer and to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. First a transmission scan without radiotracer is performed to allow corrections of the emission data. Subjects will then receive one injection of 18F-fluorodeoxyglucose (FDG). Subjects may not move during the scans. The total procedure should take two to two-and-a-half hours.
RADIATION/CHEMICAL SUBSTANCES
18F-fluorodeoxyglucose (FDG)
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray).
There is no increase in risk associated with use of the rubber bellows.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
These PET studies are carried out at the University of California, San Francisco.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 02/08/02
IRB approval number: 2002-2-32
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: University of California, San Francisco
Most recent approval: 08/14/02
IRB approval number: H5619-18931-01
Explanation of additional approval:
Full approval by UCSF is a condition of approval from the LBNL IRB and must therefore precede the LBNL approval date.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 02/08/02 to 09/30/02
Explanation:
Initial period of protocol approval falling within the fiscal year.
Type(s) of Human Subjects Involvement:
TITLE: Evaluation of Dynamic ECT Algorithms for Inconsistent Projection Data
OBJECTIVES
The purpose of this project is to test mathematical algorithms for the analysis of data produced by single photon emission computed tomography (SPECT) studies. The individual subjects will be heart patients who have been prescribed a cardiac SPECT scan by their personal physicians. Society would benefit from more accurate and economical diagnostic tests.
METHODOLOGY
Up to 5 healthy human volunteers will be sought through advertisement. Subjects will receive a standard SPECT scan, described below, with one or two rubber bellows placed around the torso to monitor breathing movement.
Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm to inject the radiotracer and to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. First, the subject is given a chest x-ray to allow corrections of the emission data. Subjects will then receive one injection of thallium-201. Subjects may not move during the scans. The total procedure should take one to one-and-a-half hours.
RADIATION/CHEMICAL SUBSTANCES
Thallium-201
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
SPECT scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
These SPECT studies are carried out at the University of California, San Francisco.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 09/23/02
IRB approval number: 2002-10-14
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: University of California San Francisco
Most recent approval: 08/22/02
IRB approval number: H260-15408-05
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: List Mode Data Acquisition for Clinical PET Studies and Retrospective Gating of Cardiac and Respiratory Motion
OBJECTIVES
The small movements of the chest caused by breathing and the beating of the heart currently degrades the quality of positron emission tomograph (PET)images. The purpose of this project is to evaluate the utility of motion compensation in PET studies. The individual subjects will be heart patients who have been prescribed a cardiac PET scan by their personal physicians. Society would benefit from more accurate and economical diagnostic tests.
METHODOLOGY
Subjects will receive a standard PET scan, described below, with one or two rubber bellows placed around the torso to monitor breathing movement.
Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm to inject the radiotracer and to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. First a transmission scan without radiotracer is performed to allow corrections of the emission data. Subjects will then receive one injection of 18F-fluorodeoxyglucose (FDG). Subjects may not move during the scans. The total procedure should take two to two-and-a-half hours.
RADIATION/CHEMICAL SUBSTANCES
18F-fluorodeoxyglucose (FDG)
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray).
There is no increase in risk associated with use of the rubber bellows.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
These PET studies are carried out at the University of California, San Francisco.
"Alzheimer's Disease as a Systemic Disorder"
Principal Investigator: Dr. Thomas F. Budinger, Lawrence Berkeley National Laboratory
Project started in: 1984
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 03/14/01
IRB approval number: 2001-3-51
Explanation of IRB approval:
Protocol was discontinued in February, 2002.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 03/14/01 to 02/22/02
Explanation:
Final time period during which protocol was approved.
Type(s) of Human Subjects Involvement:
TITLE: Cardiovascular Relationships in Alzheimer's Disease --Determination of Peripheral Vascular Reactivity
OBJECTIVES
The goal of this study is to demonstrate the presence or absence of strong correlations between Alzheimer's disease (AD) and peripheral cardiovascular disease. Societal benefits may include a greater understanding of dementing illnesses.
METHODOLOGY
An equal number of control subjects and AD patients will be recruited. Patient subjects are accompanied by an adult family member or guardian to assure an appropriate consent process. AD patients will have been previously evaluated by their treating clinic and these results will be made available to the researchers.
On the day of the study, a small sample of venous blood will be drawn for lipoprotein analysis in order to correlate LDL levels, reactivity and subject illness. Vascular reactivity to the tightening and releasing of a blood pressure cuff will then be non-invasively measured using a Food and Drug Administration approved Doppler flow system.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
None
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include: venous catheter (bruising, faintness), discomfort due to the squeezing of the blood pressure cuff.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. The results from the venous blood analysis are supplied to the patients' personal physicians upon request. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena. In patients whose cognition is or may be impaired, the consent of the responsible next of kin or conservator as well as the assent of the patient will be sought.
PROTOCOL DISCONTINUED IN FEBRUARY, 2002.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/05/02
IRB approval number: 2002-4-70
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 15
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Evaluation of Vascular Reactivity in Alzheimer's Disease via Iontophoresis of Vasoactive Compounds
OBJECTIVES
The goal of this study is to continue to examine the presence or absence of strong correlations between Alzheimer's disease (AD) and peripheral cardiovascular disease. Societal benefits may include a greater understanding of dementing illnesses.
METHODOLOGY
An equal number of control subjects and AD patients will be recruited. Patient subjects are accompanied by an adult family member or guardian to assure an appropriate consent process. AD patients will have been previously evaluated by their treating clinic and these results will be made available to the researchers.
Subjects will fast for 12 hours prior to their study. On the day of the study, subjects will be screened for factors such as the use of aspirin. A small sample of venous blood will be drawn for lipoprotein analysis in order to correlate LDL levels, reactivity and subject illness. A picture of the blood vessels in the hand will be taken using a laser scanner. The laser is similar in intensity to a laser pointer and is not damaging to the skin.
Areas of the skin will be cleaned using isopropyl alcohol. Small amounts of up to five vasodilators and/or constrictors will be dabbed onto the subject's skin. A one inch square electrode will be placed over the applied chemical, and a tiny electric current applied to cause the chemical to move into localized areas the skin and underlying capillaries. Changes in the circulation will then be non-invasively measured using the same non-invasive laser scanner described above.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
The vasodilators and/or constrictors which may be applied to localized areas of the skin of the arm are: sildenafil citrate; nitro-L-arginine methy ester; nitroprusside; methacholine; acetylcholine. None of the applications will result in a significant or even measurable systemic dose.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include: venous catheter (bruising, faintness); minor skin irritation or allergic reaction from the chemicals applied to the skin; a slight, transient tingling feeling from the iontophoresis electrode.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. The results from the venous blood analysis are supplied to the patients' personal physicians upon request. Subjects are reminded that research records are not immune to subpoena. In patients whose cognition is or may be impaired, the consent of the responsible next of kin or conservator as well as the assent of the patient will be sought.
"Red Cell Deformability In Vitro and Survival In Vivo"
Principal Investigator: Dr. Mohandas Narla, Lawrence Berkeley National Laboratory
Project started in: 1990
This project ended in fiscal year 2002.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: Narla 1
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/18/01
IRB approval number: 2001-4-102
Explanation of IRB approval:
This project was discontinued in early 2002.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
OBJECTIVES
The objective of this study is to clarify the contributions of reduced cellular deformability to increased red cell destruction in various human hemolytic disorders and to define the biochemical and structural basis for the deformability changes. Another objective is to develop a detailed understanding of red cell membrane physiology as it relates to red cell function in vivo through biophysical characterization of normal and pathologic red cells. In so doing, a greater understanding of sickle cell disease and potential treatment regimes may be developed.
METHODOLOGY
Blood samples for analysis are obtained by venipuncture under another protocol (see below). Some samples are obtained from blood donors with sickle cell or other thalassemias. The samples are then analyzed.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Human involvement in this study is limited to the analysis of blood collected under another study, "Red Blood Cell Membrane" (subprotocol Narla 1, LBNL-91-068-H03, M. Narla, principle investigator). Blood is collected by routine clinical venipuncture, which carries with it small risks of bruising or bleeding and a remote risk of infection. Please note that the number of subjects participating under this protocol is reported on under protocol Narla 1, project LBNL-91-068-H03.
CONFIDENTIALITY
The samples are not anonymous, but only aggregate data is published or reported.
This project was discontinued in March of 2002.
"Red Cell Membrane"
Principal Investigator: Dr. Mohandas Narla, Lawrence Berkeley National Laboratory
Project started in: 1991
This project ended in fiscal year 2002.
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 01/25/01
IRB approval number: 2001-9-30
Explanation of IRB approval:
This project was discontinued in early 2002.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
"Red Cell Membrane Skeleton and Malaria Infection"
OBJECTIVES
The objective of this study is to obtain a detailed understanding of the role of selected red cell skeletal proteins in regulating membrane function. The purpose of this subprotocol is the investigation of the effects of malaria infection on red blood cells in vitro.
METHODOLOGY
Blood samples for malarial infection are obtained by venipuncture.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Human subject involvement is limited to the donation of blood for analysis via routine clinical venipuncture, which carries with it small risks of bruising or bleeding and a remote risk of infection.
CONFIDENTIALITY
No personal information is collected from the subjects. The identities of the donors are known to the researcher and the phlebotomist, but individual samples are not identified.
This project was discontinued in early 2002.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 01/17/01
IRB approval number: 2001-4-100
Explanation of IRB approval:
This project was discontinued in early 2002.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
"Red Blood Cell Studies"
OBJECTIVES
The objective of this study is to obtain a detailed understanding of the role of selected red cell skeletal proteins in regulating membrane function. Several subprojects approach this through characterization of specific proteins and manipulation of the corresponding cloned genes. These studies will aid in the formation of better diagnostic and treatment tools for patients with sickle cell conditions.
METHODOLOGY
Blood samples for analysis are obtained by venipuncture. Some samples are obtained from blood donors with sickle cell or other thalassemias.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Human subject involvement is limited to the donation of blood for analysis via routine clinical venipuncture, which carries with it small risks of bruising or bleeding and a remote risk of infection.
CONFIDENTIALITY
The samples are not anonymous, but only aggregate data is published or reported.
This project was discontinued in early 2002.
"National Runners and Walkers Health Study"
Principal Investigator: Dr. Paul T. Williams, Lawrence Berkeley National Laboratory
Project started in: 1991
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: Williams 3
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 02/26/02
IRB approval number: 2001-12-53
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 161242
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The objective of this study is to collect self-reported and medical history data as a basis for testing for correlations between various conditions (e.g., lung cancer and heart disease), running activity, and smoking history.
The study hopes to achieve this goal by surveying active exercisers. Questionnaires are distributed to the readers of 'Runner's World' magazine and to participants in current long-distance running events; additional questionnaires were sent to the subscribers of 'Walking' magazine. 491,667 questionnaires were mailed in calendar year 2001. Subjects may also be recruited by word of mouth.
The investigator does not contact individuals who do not return an initial survey and consent statement. The survey asks questions about exercise level, diet, weight, and personal habits. Subjects are also asked to sign a release for access to their medical records. If the release is signed, the investigator sends a separate request to the physician's office where the relevant information is abstracted by the physician or his staff and returned to the investigator. These items include results of any recent blood tests for cholesterol and lipoprotein levels.
The subject's participation is limited to completing the survey and allowing access to existing medical records. The only risk to the subject is potential loss of some personal privacy. Results are not collected anonymously and subjects are asked to give the names and contact information for individuals outside the study to aid the researchers in tracking subjects longitudinally. Only aggregate research results, which do not identify individual participants, are published.
OVER 160,000 SUBJECTS HAVE ENROLLED IN THE STUDY THROUGH DECEMBER 2001.
"Rheological and Adherence Properties of Sickle Cells"
Principal Investigator: Dr. Mohandas Narla, Lawrence Berkeley National Laboratory
Project started in: 1992
This project ended in fiscal year 2002.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: Narla 1
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/18/01
IRB approval number: 2001-4-101
Explanation of IRB approval:
This project was discontinued in early 2002.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement: