Mr. Michael
Chartock
MS 50A-4112
1 Cyclotron Road
Berkeley, CA 94720-
Phone: 510-486-6669
Fax: 510-486-6866
E-mail: MAChartock@lbl.gov
Number of Human Subjects projects reported: 36
Project Identifier:
LBNL-75-001-H02
Project Title:
"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: 11
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 04/09/99
IRB approval number: 99-4-53
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: Human Tumor Evaluation by Fluorodeoxyglucose and PET
OBJECTIVES
The objective of this study is the development and use of new technologies for the study of brain tumors. The focus is on the development of advanced emission tomography imaging modalities, as well as further development of magnetic resonance imaging techniques. This study hopes to lead in the development of effective brain tumor diagnosis and staging programs.
METHODOLOGY
Subjects with confirmed brain tumors are given radiotracer enhanced positron emission tomography (PET) scans before and 18 months after radiation therapy. As part of this procedure, patients are given both a venous and an arterial catheter for the administration of the radiotracer [fluorodeoxyglucose (FDG-18)]. Children receive a second venous catheter instead of an arterial catheter.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Fluorine-18 Fluorodeoxyglucose (FDG-18) is used to enhance the PET scans.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risks include: venous catheter (bruising, faintness); arterial catheter (bruising, pain, faintness, development of a blot clot [1%]); radiation (equivalent to back x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and 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
Most recent IRB approval: 11/07/97
IRB approval number: 97-11-32
Explanation of IRB approval:
Protocol was discontinued in October, 1998.
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: 11/07/97 to 10/29/98
Explanation:
Last period during which protocol was approved.
Type(s) of Human Subjects Involvement:
TITLE: PET Study of Prostate 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 prostate 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 prostate cancer patients.
METHODOLOGY
A urinary bladder catheter will be placed to remove from the bladder any activity which might interfere with the image of the prostate. Then, 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. The subject will be followed for 3 years to evaluate the outcome of therapy with the study's analyses.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Fluorine-18 Fluorodeoxyglucose (FDG-18)
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: urinary catheter (discomfort, slight chance of urinary tract infection); 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.
THIS PROTOCOL WAS DISCONTINUED IN OCTOBER, 1998
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 10/09/98
IRB approval number: 98-10-62
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 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
Most recent IRB approval: 08/27/99
IRB approval number: 99-8-126
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
Most recent IRB approval: 12/05/97
IRB approval number: 97-12-76
Explanation of IRB approval:
Protocol was discontinued in November, 1998.
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: 12/05/97 to 11/20/98
Explanation:
Final period during which protocol was approved.
Type(s) of Human Subjects Involvement:
OBJECTIVES
To evaluate the efficacy of the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality in assessing primary and metastatic lung cancer. The subject may benefit from the detection of the presence of metastasis using PET scans. Society may benefit from an improved technique for the diagnosis and management of future lung cancer patients.
METHODOLOGY
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. 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. Every six months following these scans, telephone interviews will be conducted with the subjects to evaluate their outcome. Copies of any summaries of patient care, visits, or hospital admissions will be obtained.
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 back 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.
THIS PROTOCOL WAS DISCONTINUED IN NOVEMBER, 1998.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 09/08/99
IRB approval number: 99-8-123
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: 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.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 08/27/99
IRB approval number: 99-8-124
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: Coronary Artery Disease Evaluation by 13-Ammonia Perfusion and Deoxyglucose Uptake Measured by PET and Three-Dimensional MR Myocardial Tagging
OBJECTIVES
The purpose of this project is to develop noninvasive, rapid, and economical methods for the evaluation of myocardial perfusion and metabolism. This protocol will compare magnetic resonance imaging (MRI) strain data from rest and low dose dobutamine stress conditions to PET 13-ammonia/
18F-fluorodeoxyglucose (FDG) studies to determine which is the superior technique.
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
MRI: The standard medical procedure for myocardial tagging image will be used. Subjects will discontinue beta-blocker medications 48 hours before the procedure (with the permission of their personal physician/cardiologist). A venous catheter will be placed and heart rate and blood pressure monitors attached. After a resting MRI, dobutamine will be administered as a cardiac stressor. Drugs to counteract the effect of the dobutamine, if needed, will be on hand.
PET: Patients will fast the night before scanning. Subjects are offered water before their study begins. 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. First the 13-ammonia scan is performed. Subjects are then allowed to void if necessary. Then a transmission scan without radiotracer is performed to allow corrections of the emission data. Lastly, the 18-FDG study is done. Subjects may not move during the scans. The total procedure should take about 120 minutes.
RADIATION/CHEMICAL SUBSTANCES
MRI: dobutamine
PET: Fluorine-18 fluorodeoxyglucose; nitrogen-13 ammonia
INVOLVEMENT OF HUMAN SUBJECTS
Each of the subjects will have two MRI studies but most subjects will have only a single 13-ammonia vs 18-FDG uptake PET study.
MRI risks include: venous catheter (bruising, faintness); the discomfort of lying still in an enclosed space for a long period of time; the rare chance of an allergic reaction to dobutamine; the possibility of discomfort associated with discontinuing medication 48 hours prior to the study; and the rare possibility (as with any stress test) of arrythmia, heart attack, or death.
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: Expedited
Most recent IRB approval: 09/17/99
IRB approval number: 99-9-50
Explanation of IRB approval:
This study also received a full board review from the Committee on Human Research at the University of California, San Francisco.
Approval date: 9/3/99 Approval number: H5637-15422-02
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: 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
Most recent IRB approval: 08/27/99
IRB approval number: 99-8-125
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: Head and Neck Tumor Evaluation by Fluorodeoxyglucose and PET
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 cancer involving the head and neck. The subject may benefit from pre- and post-therapy PET scans in diagnosing and monitoring the status of his/her illness. Society may benefit from an improved technique for the diagnosis, prognosis and management of future patients with head and neck tumors.
METHODOLOGY
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. 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.
The LBNL procedures are to be applied before and after treatment. A third PET study may be performed if the first or second study suffers a correctable problem (e.g., instrument failure) and the study is deemed important to the patient, or if a third study is indicated to evaluate the long-term outcome of 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 back x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET scan(s) 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
Most recent IRB approval: 09/17/99
IRB approval number: 99-9-56
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: Melanoma Tumor Evaluation by Fluorodeoxyglucose and PET
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 melanoma as well as to follow-up to the course of treatment. The subject may benefit from pre- and post-therapy PET scans in diagnosing and monitoring the status of his/her illness. Society may benefit from an improved technique for the diagnosis and management of future patients with lymphoma.
METHODOLOGY
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. After a half-hour uptake phase and after the first hour of scanning, 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. Except as noted above, subjects may not move during the scan, which may last as long as 3 hours.
The LBNL procedures are to be applied before and after treatment. A third PET study may be performed if the first or second study suffers a correctable failure (e.g., instrument failure) and the study is deemed important to the patient, or if a third study is indicated to evaluate the long-term outcome of 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 back x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET scan(s) 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: Expedited
Most recent IRB approval: 08/27/99
IRB approval number: 99-8-140
Explanation of IRB approval:
This study received a full board review by the Committee on Human Research at the University of California, San Francisco, on May 27, 1999.
CHR approval number: H5637-14948-02
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: 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.
Project Identifier:
LBNL-75-102-H01
Project Title:
"Treatment of Cancer with Heavy Charged Particles"
Principal Investigator: Dr. Joseph R. Castro, Lawrence Berkeley National Laboratory
Project started in: 1975
This project ended in fiscal year 1999.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 05/08/98
IRB approval number: 98-5-91
Explanation of IRB approval:
This project was discontinued before its 1999 renewal was due.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
OBJECTIVES
To evaluate the effectiveness of cancer treatment under multiple protocols with heavy charged particle beams. The LBNL treatment phase of the project was discontinued after closure of the Bevalac in 1992; currently the project has been extended to allow follow-up of patients already treated. Societal benefits may include a better understanding of treatment options for individuals with cancer and a better understanding of the associated risks and side effects.
METHODOLOGY
Human subjects involvement includes follow-up of subjects already treated. The subject pool includes those treated at LBNL and at other Northern California Oncology Group sites. During 1994, a new study for the treatment of ocular melanoma was begun at the University of California at Davis (UCD) Crocker Cyclotron; subjects treated as part of that project will also be followed under this study. Follow-up includes gathering data from existing records as well as from post-treatment specific examinations.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Treatment of ocular melanoma patients with protons using the Crocker Cyclotron at UCD.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
No additional risk accrues to the subjects from participation in the follow-up study.
CONFIDENTIALITY
Patient results are published only in the aggregate.
THIS STUDY WAS DISCONTINUED NOVEMBER 12, 1998.
Project Identifier:
LBNL-77-057-H02
Project Title:
"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
Most recent IRB approval: 01/15/99
IRB approval number: 99-1-114
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.
Project Identifier:
LBNL-79-106-H02
Project Title:
"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
Most recent IRB approval: 02/12/99
IRB approval number: 99-2-74
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 18
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
Most recent IRB approval: 02/12/99
IRB approval number: 99-2-77
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 which 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 (CRC Protocol #1). 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
Most recent IRB approval: 02/12/99
IRB approval number: 99-2-74
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 343
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.
Project Identifier:
LBNL-79-108-H01
Project Title:
"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
Most recent IRB approval: 03/04/99
IRB approval number: 99-3-32
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
Most recent IRB approval: 03/04/99
IRB approval number: 99-3-32
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:
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.
Project Identifier:
LBNL-80-001-H01
Project Title:
"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: 3
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 09/08/99
IRB approval number: 99-8-123
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: 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.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 12/11/98
IRB approval number: 98-12-57
Explanation of IRB approval:
This protocol was also reviewed and approved by the Committee on Human Research at the University of California at San Francisco. It was approved 11/13/98, with a CHR approval number of: H5637-15423-01A.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
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 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.
18F-fluorodeoxyglucose (FDG) studies to determine which is the superior technique.
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 belows.
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: Full Board
Most recent IRB approval: 08/27/99
IRB approval number: 99-8-124
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: Coronary Artery Disease Evaluation by 13-Ammonia Perfusion and Deoxyglucose Uptake Measured by PET and Three-Dimensional MR Myocardial Tagging
OBJECTIVES
The purpose of this project is to develop noninvasive, rapid, and economical methods for the evaluation of myocardial perfusion and metabolism. This protocol will compare magnetic resonance imaging (MRI) strain data from rest and low dose dobutamine stress conditions to PET 13-ammonia/18F-fluorodeoxyglucose (FDG) studies to determine which is the superior technique. 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
MRI: The standard medical procedure for myocardial tagging image will be used. Subjects will discontinue beta-blocker medications 48 hours before the procedure (with the permission of their personal physician/cardiologist). A venous catheter will be placed and heart rate and blood pressure monitors attached. After a resting MRI, dobutamine will be administered as a cardiac stressor. Drugs to counteract the effect of the dobutamine, if needed, will be on hand.
PET: Patients will fast the night before scanning. Subjects are offered water before their study begins. 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. First the 13-ammonia scan is performed. Subjects are then allowed to void if necessary. Then a transmission scan without radiotracer is performed to allow corrections of the emission data. Lastly, the 18-FDG study is done. Subjects may not move during the scans. The total procedure should take about 120 minutes.
RADIATION/CHEMICAL SUBSTANCES
MRI: dobutamine
PET: Fluorine-18 fluorodeoxyglucose; nitrogen-13 ammonia
INVOLVEMENT OF HUMAN SUBJECTS
Each of the subjects will have two MRI studies but most subjects will have only a single 13-ammonia vs 18-FDG uptake PET study.
MRI risks include: venous catheter (bruising, faintness); the discomfort of lying still in an enclosed space for a long period of time; the rare chance of an allergic reaction to dobutamine; the possibility of discomfort associated with discontinuing medication 48 hours prior to the study; and the rare possibility (as with any stress test) of arrythmia, heart attack, or death.
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.
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.
Project Identifier:
LBNL-82-001-H04
Project Title:
"Quantitative Cardiovascular Research"
Principal Investigator: Dr. Thomas F. Budinger, Lawrence Berkeley National Laboratory
Project started in: 1982
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 09/09/98
IRB approval number: 98-8-126
Explanation of IRB approval:
This project was discontined 7/15/99.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
OBJECTIVES
The objective of this grant is to introduce quantitative methods of non-invasive imaging to postdoctoral and occasional predoctoral scientists, for training purposes.
METHODOLOGY
Trainees participate in research carried out under other approved protocols. No additional human subjects are recruited.
INVOLVEMENT OF AND RISK TO HUMAN SUBJECTS
Trainee researchers participated in studies carried out and reported under Research Medicine Protocols (RMPs) 49, 50 and 24 (see LBNL 80-001-H01 and LBNL-84-001-H03, respectively). No additional risks to human subjects are incurred as a result of this project.
CONFIDENTIALITY
Confidentiality provisions are reported under the individual protocols.
THIS TRAINING GRANT WAS DISCONTINUED IN JULY, 1999.
Project Identifier:
LBNL-84-001-H03
Project Title:
"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: 3
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 10/09/98
IRB approval number: 98-10-98
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: Skeletal Muscle Metabolism in Alzheimer's Disease
OBJECTIVES
Alzheimer's disease (AD) is known to be associated with change in cerebral glucose metabolism, and it has been suggested that AD is also associated with changes in muscular glucose utilization. The goal of this study is to quantify skeltal muscle glucose metabolism in subjects with Alzheimer's disease.
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, subjects will fast for about two hours. They will then be given a light meal. A detailed exercise history for the week prior to the study will be taken. A small sample of venous blood will be drawn for insulin assay; blood glucose may be adjusted using glucola.
Subjects will lie on their stomachs with their legs through the ring of the PET scanner. The subject will exercise by repeatedly depressing a foot pedal for at least 15 minutes. The radiotracer F-18-fluorodeoxyglucose will be administered about 3 minutes into the exercise session. After the leg exercise and scan, subjects will urinate to reduce the dose to the bladder and then repositioned in the PET scanner for a brain scan. No additional radiotracer will be given.
Vascular reactivity to the tightening and releasing of a blood pressure cuff will also be non-invasively measured using a Food and Drug Administration approved Doppler flow system.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Fluorine-18 Fluorodeoxyglucose
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness) and radiation (equivalent to back x-ray).
Other risks include muscle fatigue or cramping from depressing the pedal and 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.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 08/27/99
IRB approval number: 99-8-138
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 objectives of this study are to utilize magnetic resonance imaging (MRI) and positron emission tomography (PET) on patients with Alzheimer's disease, Parkinson's disease, and multi-infarct dementia to understand the longitudinal effects of these conditions on cerebral metabolism and to develop a new serotonin-based radiotracer which will provide a measure of the presynaptic degeneration in these cases; correlate the presynaptic degeneration with behavioral changes. The new tracer will also be used to investigate serotonergic degeneration in these diseases. Societal benefits may include a greater understanding of dementing illnesses.
METHODOLOGY
Subjects are accompanied by an adult family member or guardian to assure an appropriate consent process. Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm and another will be placed in an artery or vein of the hand on the other arm. The venous catheter will be used to inject the radiotracer and the arterial (or other venous) catheter will be used to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. 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 then watch a video display terminal on which words are presented. A delayed word presentation is used to determine the duration of subjects' memory. 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 60 to 90 minutes. Subsequently, the subjects may be placed in an MRI scanner for 2 scans totaling approximately 30 minutes.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Fluorine-18 Fluorodeoxyglucose
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); arterial catheter (bruising, pain, faintness); radiation (equivalent to back x-ray). If an arterial catheter is to be placed, lidocaine is used to provide local anesthesia before placing the catheter.
MRI scan risk includes: discomfort associated with lying still in an enclosed space.
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. 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.
SPECIAL NOTE
This study was formerly included in this database as a subprotocol of "Longitudinal SPECT and PET Studies of Dementia" (LBNL-88-073-H02). LBNL-88-073-H02 has now been discontinued.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 03/01/99
IRB approval number: 99-3-37
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: 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.
Project Identifier:
LBNL-88-107-H07
Project Title:
"Lipoprotein Subfractions and Coronary Heart Disease During 25-Year Follow-Up"
Principal Investigator: Dr. Paul T. Williams, Lawrence Berkeley National Laboratory
Project started in: 1988
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 02/04/99
IRB approval number: 99-2-48
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 objective of this study is to investigate the relationships of fatal and nonfatal coronary heart disease and stroke to lipoprotein subfractions and other risk factors.
This is an epidemiological study of 1,961 men and 423 women whose plasma, total cholesterol, blood pressure, height, weight, tobacco use and lipoprotein profiles were studied between 1954 and 1957. The vital status and history of coronary heart disease and stroke in this cohort will be evaluated through state and national mortality surveillance systems, public records, medical reports, hospital records, autopsy reports, and telephone interviews with cohort members.
The subjects had blood samples drawn at Lawrence Livermore Laboratory between 1954-1957. The current involvement of all members of the cohort is limited to periodic questionnaires and follow-up of medical records. Each new access to medical records requires fresh consent from the subjects.
The total living cohort numbers approximately 2,100; in FY 95-96, emphasis was placed on recontacting the approximately 400 surviving female members of the cohort. No subjects were re-contacted in 1998, but analysis of data previously collected is continuing. Results are reported or published only in the aggregate, with no individual subjects identified.
Project Identifier:
LBNL-90-007-H01
Project Title:
"Hemoglobin Conversion to Pro-Oxidants by Cigarette Smoke"
Principal Investigator: Dr. Rolf J. Melhorn, Lawrence Berkeley National Laboratory
Project started in: 1990
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 02/12/99
IRB approval number: 99-2-75
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 30
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 use isolated erythrocytes and/or hemoglobin exposed in vitro to cigarette smoke to test the hypothesis that the exposure of blood to cigarette smoke promotes the formation of free radicals by hemoglobin products. This information will help enable more informed decisions about the risks and likely results of cigarette smoking.
METHODOLOGY
Blood collected under another protocol (see below) is used as the source for the isolated erythrocytes and hemoglobin which are 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 protocol, "Lipoproteins and Atherogenesis in Transgenic Animals" (subprotocol 6), LBNL-79-106-H02 (R. Krauss, principal investigator).
CONFIDENTIALITY
While subjects are not anonymous under the source protocol, samples passed to Dr. Mehlhorn are not identified.
Project Identifier:
LBNL-90-068-H01
Project Title:
"Red Cell Deformability In Vitro and Survival In Vivo"
Principal Investigator: Dr. Mohandas Narla, Lawrence Berkeley National Laboratory
Project started in: 1990
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
Most recent IRB approval: 02/12/99
IRB approval number: 99-2-46
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:
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 94-1-65), 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.
CONFIDENTIALITY
The samples are not anonymous, but only aggregate data is published or reported.
Project Identifier:
LBNL-90-107-H02
Project Title:
"Weight Set Point and HDL Levels in Long-Distance Runners"
Principal Investigator: Dr. Paul T. Williams, Lawrence Berkeley National Laboratory
Project started in: 1990
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 06/04/99
IRB approval number: 99-6-86
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 proposes to examine the difference(s) in diet and lipoprotein metabolism in previously overweight or naturally lean men and women who run or live sedentary lifestyles. The goal is to better understand the relationship between lipoprotein metabolism and weight set-point.
Responses to a survey (see LBNL 91-107-H01) and analysis of diet records will be correlated with the results of clinical blood testing. Laboratory tests will include standard lipoprotein and cholesterol screening, including for some subjects a separately approved post-heparin lipase activity test.
The risks involved are those common to routine clinical venipuncture (bruising, slight chance of infection) and to the clinical use of the post-heparin lipase activity test (same as venipuncture; very rarely, allergic reaction).
Subjects are not anonymous to the researcher, but only aggregate results which do not identify individual subjects are published. Results of blood tests are supplied to the subjects' physicians if the subjects so request.
Project Identifier:
LBNL-91-068-H03
Project Title:
"Red Cell Membrane"
Principal Investigator: Dr. Mohandas Narla, Lawrence Berkeley National Laboratory
Project started in: 1991
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
Most recent IRB approval: 02/12/99
IRB approval number: 99-2-38
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2
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.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 08/06/99
IRB approval number: 99-8-141
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:
"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 phelobotomist, but individual samples are not identified.
Project Identifier:
LBNL-91-107-H01
Project Title:
"National Runner's 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.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 02/04/99
IRB approval number: 99-2-49
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 23000
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 long-distance running events in 1998; additional questionnaires were sent to the subscribers of 'Walking' magazine. 640,000 questionnaires were mailed in calendar year 1998. 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.
Research on female subjects enrolled after October 1, 1997 will be funded by the USAMRMC Breast Cancer Research Program.
OVER 100,000 SUBJECTS HAVE ENROLLED IN THE STUDY THROUGH JANUARY, 1999.
Project Identifier:
LBNL-92-065-H01
Project Title:
"The Oxidant and Antioxidant Balance in Wounds (Leukocyte Function in Periodontal Disease)"
Principal Investigator: Dr. John Maguire, Lawrence Berkeley National Laboratory
Project started in: 1992
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
Most recent IRB approval: 01/05/99
IRB approval number: 99-1-116
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
OBJECTIVES
The objective of this study is to investigate whether inducible nitric oxide production from neutrophils and macrophages plays a role in the development of periodontal diseases. This study will also test the hypothesis that inducible nitric oxide production is important in bacteriocidal activity. This information will aid in the management of patient cases involving periodontal diseases.
METHODOLOGY
Leukocytes and neutrophils are collected from human subjects by either rinsing the mouth with saline, from blood (venipuncture), or from surgical drain fluid obtained during surgeries conducted at the University of California, San Francisco. Human leukocytes and neutrophils are assessed for production and induction of nitric oxide; both leukocytes and neutrophils will be tested under normoxic, neutral, hypoxic and acidic conditions in vitro. Normal samples are contrasted to samples from subjects with periodontal disease.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
There is no risk to subjects rinsing with saline. Venipuncture risks include bruising, faintness, and a remote chance of infection. The drain fluids are surgical discards and cause no additional risk to the patient.
CONFIDENTIALITY
Samples from UCSF are anonymous to the Berkeley Laboratory investigator. Because blood and oral leukocyte donors are recruited from colleagues of the investigator, they are informed that their identities may be known to those working with their samples. Potential subjects are therefore encouraged to review the exclusionary criteria and self-exclude if called for to limit the potential for compromising their confidentiality. Data is reported only in the aggregate.
Project Identifier:
LBNL-92-068-H02
Project Title:
"Rheological and Adherence Properties of Sickle Cells"
Principal Investigator: Dr. Mohandas Narla, Lawrence Berkeley National Laboratory
Project started in: 1992
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
Most recent IRB approval: 02/12/99
IRB approval number: 99-2-45
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 8
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 continue the characterization of rheological and adherence properties of sickle cells and define the biochemical and structural basis for the observed alterations in these properties. In so doing, the study will aid the development of better diagnostic and treatment tools for patients with the sickle cell condition.
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 subject involvement is limited to the analysis of blood collected under another study, "Red Blood Cell Membrane" (subprotocol 94-1-65), LBNL-91-068-H03 (M. Narla, principal investigator) Blood is collected by 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.
Project Identifier:
LBNL-92-106-H04
Project Title:
"Genetic and Metabolic Factors Affecting Response of Lp(a) to Dietary Fat"
Principal Investigator: Dr. Ronald M. Krauss, Lawrence Berkeley National Laboratory
Project started in: 1992
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
Most recent IRB approval: 03/09/99
IRB approval number: 99-2-98
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 102
Reporting period for number of human subjects:
Other: 01/01/98 to 12/30/98
Explanation:
Calendar year 1998.
Type(s) of Human Subjects Involvement: