Dr. Joe
W.
Gray
MS 84R0171
1 Cyclotron Road
Berkeley, CA 94720
Phone: 510-486-2438
Fax: 510-486-2535
E-mail: jwgray@lbl.gov
Number of Human Subjects projects reported: 49
| LBNL-75-001-H02 | "Experimental Medicine Clinical" |
| LBNL-77-057-H02 | "Studies of Lipoproteins and Lipid Protein Interactions" |
| LBNL-79-108-H01 | "hTERT Reactivation During Immortalization of Human Cells " |
| LBNL-91-107-H01 | "National Runners and Walkers Health Study" |
| LBNL-92-107-H05 | "Gene Specific Responses to Exercise in Discordant Twins (Formerly, "Effects of Running on HDL and LDL Subclasses of MZ Twins")" |
| LBNL-98-107-H06 | "National Health Survey on the Internet" |
| LBNL-98-139-H01 | "Breast Cancer Specific PET Instrumentation" |
| LBNL-00-005-H01 | "Training in Mammary Gland Biology and Breast Cancer" |
| LBNL-00-143-H01 | "Novel Functions for Red Cell Proteins Lu and LW" |
| LBNL-01-063-H01 | "Estrogen Receptors in the Brain" |
| LBNL-01-109-H02 | "Indoor Bioaerosol Detection and Quantification by Polymerase Chain Reaction (PCR)" |
| LBNL-02-186-H01 | "Chelation Therapy Using Calcium DTPA and/or Zinc DTPA for Internal Contamination with Plutonium and Other Transuranic Elements" |
| LBNL-03-130-H01 | "Nu 99G8: The National Ovarian Cancer Early Detection Program - Molecular Cytogenetic Detection of Early Cancer" |
| LBNL-03-194H01 | "Advanced Techniques in Latent Fingerprint Detection, Visualization and Analysis" |
| LBNL-03-207-H01 | "Advancing Electrochromic Windows" |
| LBNL-03-85-H04 | "Evaluation of Iodorotenone, a SPECT Perfusion Tracer" |
| LBNL-03-99H01 | "Role of CYP1B1 in PAH-DNA Adduct Formation and Breast Cancer" |
| LBNL-04-107H06 | "Long-Term Exercise Maintenance via Internet Support" |
| LBNL-04-130H02 | "The Biology of Ovarian Cancer: Genome Evolution and Gene Discovery in Ovarian Cancer" |
| LBNL-04-161H02 | "Human DNA Re-Sequencing: Slavotinek Samples" |
| LBNL-04-161H03 | "Human DNA Re-Sequencing: McPherson Obesity Samples" |
| LBNL-04-161H04 | "Human DNA Re-Sequencing: Dr. Joe Gray Collaboration" |
| LBNL-04-161H05 | "Human DNA Re-Sequencing: Melanoma Samples" |
| LBNL-04-161H06 | "Human DNA Re-Sequencing: Read Collaboration" |
| LBNL-04-161H07 | "Human DNA Re-Sequencing: McPherson Samples (Coronary Artery Disease)" |
| LBNL-04-184-H03 | "Dynamic Cardiac SPECT Imaging" |
| LBNL-04-184-H04 | "Improved Cardiac SPECT with Convergent Hole Collimators" |
| LBNL-04-189H01 | "Classroom HVAC: Improving Ventilation and Saving Energy" |
| LBNL-04-207-H02 | "Cost-Effective Daylighting Solutions" |
| LBNL-04-213H01 | "Comparative Community Genomics of the Gut Microbiota" |
| LBNL-04-223H01 | "DNA Repair in Artemis Deficiency" |
| LBNL-04-225H01 | "The rSBH System for Comprehensive Pathogen Diagnostics" |
| LBNL-04-73H01 | "Brain Imaging with [F18]-Fluorodeoxyglucose (FDG) in Adult Males and Females-New Methods for Analyzing PET Data" |
| LBNL-04-85H01 | "Brain Imaging with [F-18]-Fluorometatyrosine in Adult Males and Females: Implications for Parkinson's Disease" |
| LBNL-05-130H04 | "SPORE Ovarian Cancer: Markers for Assessment for Response to Therapy" |
| LBNL-05-161H08 | "Human DNA Resequencing: Absence of the Corpus Callosum" |
| LBNL-05-161H10 | "Human DNA Re-Sequencing: Greenwood Genetic Center Samples" |
| LBNL-05-180H04 | "Low-Field Magnetic Resonance Imaging of the Wrist and Arm" |
| LBNL-05-189H03 | "Simple Exposure Indicators for ETS Particles" |
| LBNL-05-194H03 | "Identification of Common Contaminents in Latent Fingerprints" |
| LBNL-05-208H03 | "Culture-Independent Microbial Study of Endotracheal Aspirates from Intubated Patients" |
| LBNL-05-226H01 | "Comparison of Helium Ion and Proton Therapy Techniques for Treatment of Uveal Melanoma" |
| LBNL-05-236H01 | "Occupants' Control of Window Blinds in Private Offices" |
| LBNL-05-243H01 | "Culture-Independent Identification and Characterization of Microbial Community Associated with Bacterial Vaginosis" |
| LBNL-05-34H07 | "Resequencing of Candidate Genes from Patients with Brain Malformations" |
| LBNL-05-73H02 | "Dopamine Metabolism Imaging and Cognition in Aging" |
| LBNL-05-73H03 | "Amyloid Imaging in Aging, Cognitive Decline, and Dementia" |
| LBNL-05-73H04 | "Berkeley Aging Cohort Study" |
| LBNL-05-85H05 | "A Phase I Open-Label Safety Study of Intrastriatal Infusion of Adeno-Associated Virus Encoding Human Aromatic L-Amino Acid Decarboxylase (AAV-hAADC-2) in Subjects with Advanced Parkinson's" |
"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: 9
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 11/16/04
IRB approval number: 2003-10-85
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); internal exposure to radiation (equivalent to kidney x-ray); external exposure from the transmission scan (equivalent to the amount of background radiation the average person receives in one week).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and/or magnetic resonance imaging (MRI) 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
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 06/10/05
IRB approval number: 2004-6-127
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 7
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Assessment of Maximum Vasodilatory 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 60 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 12 hours before being in the 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 to 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 one. 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 using 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 using 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 the use of blood pressure cuffs to block blood supply to the arm has been shown to be safe for up to 30 minutes and 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. Test results are discussed with the subjects. Subjects are reminded 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: 11/17/04
IRB approval number: 2004-8-51
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: 11/17/04 to 09/30/05
Explanation:
Initial period of approval falling within fiscal year.
Type(s) of Human Subjects Involvement:
TITLE: Temporomandibular Joint Disease and Metabolism of Muscles of Mastication: PET Imaging
OBJECTIVES
The researchers hypothesize that temporomandibular joint (TMJ) disease may be cause by fatigue due to excessive pressure on the jaw by the surrounding muscles. The aim of this research is examine the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality as a means to more accurately diagnose and monitor the efficacy of therapy for TMJ disease.
METHODOLOGY
Up to 10 TMJ patients between the ages of 18 to 75 will be recruited from the Temporomandibular Disease/Orofacial Pain Clinic at the University of California at San Francisco (UCSF). Potential subjects are recruited by clinic staff, and those who agree will have their contact information forwarded to the Berkeley Lab. Subjects will be given an in-depth screening, including a pregnancy test for women, after formally consenting to the research. Each subject will undergo one PET scan of the head and jaw muscles at rest.
PET Scan Procedure: Subjects will be given water to drink to provoke urination. A catheter will be placed in a vein in one arm to inject the radiotracer. Immediately prior to entering the scanner, subjects are asked to urinate to keep the radiation dose 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 (FDG-18)
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising and faintness), internal radiation (equivalent to three years of natural background radiation or an x-ray computed tomograph of the abdomen), and external radiation exposure from the transmission scan (equivalent to the amount of background radiation the average person receives in one week).
CONFIDENTIALITY
Subjects will be asked to sign a Health Insurance Portability and Accountability Act (HIPAA) research authorization to allow the researchers access to their TNJ-related medical information. The identities of the subjects are known, but any public report is by code numbers only. Results from PET and/or magnetic resonance imaging (MRI) scans are supplied to the patients' personal physicians. 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: 09/02/04
IRB approval number: 2004-6-292
Explanation of IRB approval:
This project was discontinued in July of 2005.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 26
Reporting period for number of human subjects:
Other: 10/01/04 to 07/07/05
Explanation:
This project was discontinued in July of 2005.
Type(s) of Human Subjects Involvement:
TITLE: Genetics and Brain Growth
COLLABORATING INVESTIGATORS: P. Thomas Schoeneman, PhD (University of Pennsylvania); Bruce T. Lahn, PhD (University of Chicago); and Kathleen T. Brennan, DVM (LBNL)
OBJECTIVES
The purpose of this study is to build on an earlier project comparing brain size and cognitive ability among 36 female sibling pairs. Under this protocol, cheek swabs will be analyzed for two genes believed to be related to brain size, the abnormal spindle-like microcephally (ASPM) and microcephalin genes. The results will be correlated with cognitive ability and brain-size data previously collected.
METHODOLOGY
The same 72 women who participated in the original study will be recruited. Subjects who consent will be sent a cheek cell sample collection kit, instructions on the kit's use, and a pre-paid mailer for returning the sample.
The cells collected on the swab will be used as sources for DNA. The DNA will only be analyzed for the two genes of interest, ASPM and microcephalin. Material remaining after the analysis will be discarded.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
There is no known risk from use of the cheek swab.
PRIVACY/CONFIDENTIALITY/CONSENT
Subjects will be recruited through direct mail from the Berkeley Lab investigators. Included in the package with the letter will be a consent form and a copy of the publication that resulted from the original research. Only subjects who return a signed consent form will be sent a kit for the collection of cheek cells.
The identities of the subjects are known, but any public report is by code numbers only. The results of the tests will not be shared or discussed with the subjects.
This project was discontinued in July of 2005.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 08/26/04
IRB approval number: 2004-8-6
Explanation of IRB approval:
As of September 30, 2005 approval for FY 2005 was still pending some revisions required by the institutional review board.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5
Reporting period for number of human subjects:
Other: 08/26/04 to 06/16/05
Explanation:
Period between initial approval of the protocol and submission for renewal in FY2005.
Type(s) of Human Subjects Involvement:
TITLE: TMJ PET Imaging and the Study of Muscular Components of the Face
OBJECTIVES
To evaluate the efficacy of the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality in imaging the muscles involved in chewing. The researchers hypothesize that temporomandibular joint (TMJ) disease may be caused by fatigue due to excessive pressure on the jaw by the surrounding muscles. While there is no direct benefit to the subjects, society as a whole may benefit from an improved technique for the diagnosis and management of temporomandibular joint disease.
METHODOLOGY
Up to 30 normal controls, half male and half female, will be recruited by advertising in local newspapers. Potential subjects will be briefly screened over the telephone, then given a more in-depth screening, including a pregnancy test for women, after formally consenting to the research. Each subject will undergo two PET scans of the head and jaw muscles. The first scan will be done at rest; the second scan will be done to two weeks later. Prior to the second scan the subject will chew the gum of their choice for up to four hours, until the muscles of the jaw become fatigued.
The procedure for both scans is the same. Subjects will be given water to drink to provoke urination. A catheter will be placed in a vein in one arm to inject the radiotracer. Immediately prior to entering the scanner, subjects are asked to urinate to keep the radiation dose 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 (FDG-18)
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risks include: venous catheter (bruising and faintness), internal radiation exposure (equivalent to nine years of natural background radiation or an x-ray computed tomograph of the abdomen), and external exposure from the transmission scan (equivalent to the amount of background radiation the average person receives in one week). Chewing gum for an hour or longer may result in jaw pain; if this occurs, the subject will be instructed to stop chewing and will proceed immediately to the PET scan.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and/or magnetic resonance imaging (MRI) 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:
Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/21/04
IRB approval number: 2004-1-18
Explanation of IRB approval:
This protocol was discontinued by the researcher on June 2, 2005.
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: 10/01/04 to 06/02/05
Explanation:
This project never began and the researchers opted to discontinue it in June of 2005.
Type(s) of Human Subjects Involvement:
TITLE: Quantification of Endothelial Progenitor Cells and White Cell Metabolism in the Normal Population
OBJECTIVES
The researcher hypothesizes that Alzheimer's disease (AD) is a systemic condition. A possible mechanism for the disease may be a defect in the ability of an individual's progenitor endothelial cells to repair the endothelium of capillaries. The goals of this project are to determine the reliability of an assay for progenitor endothelial cells and to study white cell metabolism in normal adults.
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.
Up to 30 normal subjects, half male and half female, will be recurited by advertising in local papers. The subjects will come to Berkeley Lab, where they will be screened for serious systemic disease and have a 20 cc sample of venous blood drawn. After testing, the subjects blood sample will be discarded.
IONIZING RADIATION, RADIOACTIVE OR CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include those common to a routine venous blood draw: bruising, faintness, and very rarely, infection.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Blood samples are coded, and only the researcher has access to the code key. The results from the blood tests are not provided to subjects.
This project never began and the researchers discontinued it in June of 2005.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 03/09/05
IRB approval number: 2004-3-67
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: 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 30 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 to 220 mmHg (slightly tighter than used for normal blood pressure measurements) for four to six 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. Electrocardiogram (EKG) electrodes will be attached. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 to 220 mmHg (slightly tighter than used for normal blood pressure measurements) for about four 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 four to six 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: 04/22/05
IRB approval number: 2004-3-56
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: 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 30 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 subjects 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
Internal exposure to Carbon-11 Choline as a radiotracer. (This is a Radioactive Drug Research Committee monitored compound.) External exposure during the PET transmission scan.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); internal exposure to radiation from the tracer (equivalent to kidney x-ray); external exposure from the transmission scan (equivalent to the amount of background radiation the average person receives in one week).
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: 04/12/05
IRB approval number: 2004-3-55
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: 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 30 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
Internal exposure to Carbon-11 Choline as a radiotracer. (This is a Radioactive Drug Research Committee monitored compound.) External exposure during the PET transmission scan.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); internal exposure to radiation from the tracer (equivalent to kidney x-ray); external exposure from the transmission scan (equivalent to the amount of background radiation the average person receives in one week).
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.
"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: 06/08/05
IRB approval number: 2004-5-126
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
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 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 in this training grant.
NO POST-DOCTORAL TRAINEES PARTICIPATED IN HUMAN SUBJECTS RESEARCH IN FISCAL YEAR 2005.
"hTERT Reactivation During Immortalization of Human 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: 06/15/05
IRB approval number: 2004-2-25
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.
No human milk samples were collected by the researcher in FY2005.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 06/15/05
IRB approval number: 2004-2-25
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 and 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.
No new samples were received by the researcher during FY2005.
"National Runners and Walkers Health Study"
Principal Investigator: Dr. Paul T. Williams, Lawrence Berkeley National Laboratory
Project started in: 1991
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: 05/05/05
IRB approval number: 2004-6-38
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 159847
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. In total 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.
No new subjects were recruited in FY2005.
"Gene Specific Responses to Exercise in Discordant Twins (Formerly, "Effects of Running on HDL and LDL Subclasses of MZ Twins")"
Principal Investigator: Dr. Paul T. Williams, Lawrence Berkeley National Laboratory
Project started in: 1992
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: Williams 4
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 10/07/05
IRB approval number: 2003-8-83
Explanation of IRB approval:
Approval for renewal was a few weeks late due to an administrative back up in the IRB office.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 132
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
This study has two specific aims: (1) to estimate the effects of high level exercise and reduced adiposity on blood lipoprotein apolipoproteins and circulating triglyceride levels and (2) to test whether the effects of adiposity and exercise on lipoprotein concentrations are genotype dependent.
The study utilizes a national survey ("The National Runners Health Study," LBNL-91-107-H01) to identify identical twins with discordant cardiovascular activity levels. The researcher has developed a population of such twins who are willing to participate in the study. Participation consists of completing an additional questionnaire and having blood drawn when the volunteer enters the study and again after two years as a follow-up. Serum samples are obtained by routine venipuncture through either the subject's own physician or through a local lipoprotein screening program. The risks are those common to clinical venipuncture (bruising and the slight chance of infection).
Results are not collected anonymously, and twins will know that their sibling is enrolled in the study. Subjects are also 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 that do not identify individual participants are published.
The subject pool was previously set at 66 twin pairs. The researcher has requested and received approval to increase his subject population to 200 male and 200 female twin pairs.
"National Health Survey on the Internet"
Principal Investigator: Dr. Paul T. Williams, Lawrence Berkeley National Laboratory
Project started in: 1998
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: Williams 5
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/01/05
IRB approval number: 2004-3-19
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:
OBJECTIVE
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), vigorous exercise, and general health history (e.g., smoking and alcohol consumption).
METHODOLOGY
The researchers have posted an extensive questionnaire on health and life style on the internet. The survey is completed on line, and future follow-ups will also be distributed electronically. An extensive series of interactive features such as construction of a personal food consumption 'pyramid' are available without enrolling in the study. In order for the survey to be forwarded to the researcher's web site, potential subjects must give their age and ask to enroll, complete the entire survey, and respond affirmatively to a second consent statement after completing the study.
The survey asks questions about exercise type and level, diet, weight, health history, and personal habits. Subjects are also asked to print out and 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 the staff and returned to the investigator. These items include results of any recent blood tests for cholesterol and lipoprotein levels.
RISKS/PRIVACY/CONFIDENTIALITY
Minors are excluded from participation in the study. 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 that do not identify individual participants are published.
OVER 12,000 SUBJECTS HAVE ENROLLED IN THIS STUDY SINCE ITS INITIATION.
During the 2004 to 2005 protocol approval period, there were production problems with the website and no new visitors were enrolled.
"Breast Cancer Specific PET Instrumentation"
Principal Investigator: Dr. William W. Moses, Lawrence Berkeley National Laboratory
Project started in: 1998
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: 04/20/05
IRB approval number: 2004-5-138
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:
Abstract:
No protocols have as yet been developed for this project because the positron emission tomography (PET) imaging system is still under development. No human subjects involvement is anticipated before FY2006. This project was therefore certified to the National Institutes of Health noting that this activity contains multiple projects, some of which have not been approved.
"Training in Mammary Gland Biology and Breast Cancer"
Principal Investigator: Dr. Mina Bissell, Lawrence Berkeley National Laboratory
Project started in: 2000
This project ended in fiscal year 2005.
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: 11/15/04
IRB approval number: 2002-11-55
Explanation of IRB approval:
This study has been completed and the protocol is discontinued.
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: 10/01/04 to 09/13/05
Explanation:
This study has been completed and the protocol is discontinued.
Type(s) of Human Subjects Involvement:
Abstract:
OBJECTIVE
To provide post-doctoral training opportunities in breast cancer research that focus on molecular biology and cellular microenvironment in mammary gland biology.
In FY2004, only animal research and exempt projects were undertaken by the trainees. Future human subjects research is possible, but is expected to continue to be limited to the use of pre-existing, anonymous human cell lines.
This study has been completed and the protocol is discontinued as of September 2005.
"Novel Functions for Red Cell Proteins Lu and LW"
Principal Investigator: Dr. Joel Chasis, Lawrence Berkeley National Laboratory
Project started in: 2000
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: 04/22/05
IRB approval number: 2004-4-134
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 project is an extension of the work begun under LBNL-91-068-H03, which was discontinued in fiscal year 2002.
OBJECTIVES
The overall purpose of this study is to develop a detailed understanding of red cell membrane physiology as it relates to red cell function. This study will focus on the contributions of cell membrane erythrocyte adhesion proteins Lu (Lutheran) and LW (Landsteiner Wiener).
METHODOLOGY
Up to ten subjects with Lu or LW red blood cell abnormalities and ten normal controls will be recruited per year. One 5 to 10 ml blood draw will be obtained from each subject for in vitro analysis.
IONIZING RADIATION, RADIOACTIVE OR CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
All the subjects will be in a clinically stable state in which they can safely undergo phlebotomy. Blood is collected by routine clinical venipuncture, which carries with it small risks of bruising or bleeding and the remote risk of infection.
CONFIDENTIALITY
The samples are not anonymous, but only aggregate data are published or reported.
"Estrogen Receptors in the Brain"
Principal Investigator: Dr. Thomas F. Budinger, Lawrence Berkeley National Laboratory
Project started in: 2001
This project ended in fiscal year 2005.
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: RMP 71
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 10/20/04
IRB approval number: 2003-8-140
Explanation of IRB approval:
This study was discontinued in August of 2005.
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: 08/21/04 to 08/20/05
Explanation:
This study was discontinued in August of 2005.
Type(s) of Human Subjects Involvement:
TITLE: Estrogen Receptors (ER) in the Brain
OBJECTIVES
The use of tamoxifen as hormonal chemotherapy in breast cancer is often associated with brain-related side effects such as hot flashes, depression, and cognitive impairment, as well as increased risk of certain other kinds of cancer and cardiovascular disease. The researchers hypothesize that the brain-related side effects are caused by tamoxifen occupying and blocking estrogen receptor subtypes in different areas of the brain. In this study, the distribution of estrogen receptors in the brains of three subject groups will be assessed using a novel radiotracer, fluorine-18 fluoroestradiol, and positron emission tomography (PET).
METHODOLOGY
The researchers will initially study 20 healthy postmenopausal women, 10 already taking estrogen replacement therapy, and 10 not taking any hormones. Researchers will also study 10 postmenopausal women diagnosed with breast cancer and prescribed tamoxifen by their physicians; subjects in this group will be studied before beginning tamoxifen treatment and after 12 months of treatment. All subjects will be under the care of physicians not associated with the study, and no treatment plans will be changed in any way as part of the study. Prior to the scans, a short medical history will be taken to ensure that inclusion/exclusion criteria are met. Subjects will also be given a standard set of neuropsychological tests. Each subject will receive a magnetic resonance imaging (MRI) scan of the brain at the Neuroscience Center of the University of California, Berkeley.
PET studies will be performed at Berkeley Lab. Subjects will be offered water to promote urination. A catheter will be placed in a vein in one arm to inject the radiotracer. Subjects are asked to empty their bladder just prior to entering the scanner and just after leaving it 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. For breast cancer subjects, a second scan will be performed 12 months following the initial scan to evaluate changes resulting from tamoxifen therapy.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Internal exposure to the radiotracer Fluorine-18 fluoroestradiol (a Radioactive Drug Research Committee monitored compound). External exposure to radiation during the PET transmission scan.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
MRI scan risks include: discomfort associated with lying still in an enclosed space.
PET scan risk includes: venous catheter (bruising and faintness), internal exposure to radiation from the tracer (equivalent to kidney x-ray), and external exposure to radiation from the transmission scan (equivalent to the amount of background radiation the average person receives in one week).
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.
UPDATE: This study was discontinued in August of 2005.
"Indoor Bioaerosol Detection and Quantification by Polymerase Chain Reaction (PCR)"
Principal Investigator: Mr. William Fisk, Lawrence Berkeley National Laboratory
Project started in: 2001
This project ended in fiscal year 2005.
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: 08/11/04
IRB approval number: 2003-8-86
Explanation of IRB approval:
This study was discontinued in October of 2004.
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: 10/01/05 to 10/08/05
Explanation:
This study was discontinued in October of 2004.
Type(s) of Human Subjects Involvement:
CO-INVESTIGATOR: Regine Goth-Goldstein, PhD
OBJECTIVE
This study will develop a quantitative assay for rhinoviruses (the viruses which cause about half of all common colds) and use this assay to characterize the size distribution of droplets produced by the sneezing, etc., of cold victims. Understanding the size distribution of airborne rhinovirus may facilitate future development of control measures such as filtration and ventilation.
METHODOLOGY
The first step of the project is the development of an in-vitro polymerase chain reaction (PCR) assay for rhinoviruses. Once the assay is developed, study participants will be recruited to provide test samples for size determination of virus-containing aerosols. Test samples will collected by placing subjects in an office-sized research chamber for three to four hours, while chamber air is sampled with a "multistage inertial impactor" that collects particles in various size ranges. Analysis of these samples by PCR will indicate the size distribution.
IONIZING RADIATION, RADIOACTIVE/CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF HUMAN SUBJECTS
Employees of Berkeley Lab will be recruited by posted flyers. Subjects will initially complete a brief survey about their cold symptoms and general health, then produce a mucous sample by sniffing a saline spray, and blowing into a small collection cup.
Subjects will be asked to spend three to four hours in an office-sized research chamber (27 square meters). The room includes a window and is furnished with a desk, computer, television, and a cot. A timed audio record will be made of sneezing/coughing, and continuous samples of aerosols taken. Subjects are free to leave the room at any time.
RISKS
The study is non-invasive and was found to be of minimal risk. Neither an employee's lack of participation nor their decision to participate and subsequent test results will in any way affect their employment status at LBNL.
PRIVACY/CONFIDENTIALITY/CONSENT
Information gathered from this study is not placed in the participant's employee medical file. Because of the length of time needed for the study, subjects are informed as part of the consent process that their supervisor's approval must be obtained. Participants are reminded that co-workers may also learn of their status through simple observation. Only aggregate results without identifiers will be published. Subjects will not be reimbursed directly, but the wage expense incurred during their participation may be billed to the research account.
This study was discontinued in October of 2004.
"Chelation Therapy Using Calcium DTPA and/or Zinc DTPA for Internal Contamination with Plutonium and Other Transuranic Elements"
Principal Investigator: Dr. Peter Lichty, Lawrence Berkeley National Laboratory
Project started in: 2002
This project ended in fiscal year 2005.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 12/01/03
IRB approval number: 2004-6-126
Explanation of IRB approval:
This protocol was formally discontinued in April of 2005.
Additional IRB approvals from other institutions:
Type of Review:
Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/20/03
Explanation of additional approval:
This protocol was discontinued in April of 2005. The substances in question are no longer considered to be experimental.
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: 10/01/04 to 04/11/05
Explanation:
This protocol was discontinued in April of 2005.
Type(s) of Human Subjects Involvement:
OBJECTIVES
The purpose of this research is to make chelation therapy with calcium DTPA (diethylenetriamine pentaacetate) available to Berkeley Lab employees, guests, students, and contractors who become internally contaminated with plutonium or some other transuranic element. The research will also gather information about the effectiveness and risks of calcium and zinc DTPA.
METHODOLOGY
Only persons accidentally contaminated with plutonium or another transuranic element will be recruited. The dose and treatment schedule will be individually determined for each subject. The level of contamination will be monitored by blood and urine tests.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Zinc and calcium DTPA (diethylenetriamine pentaacetate). Until recently, these two compounds were considered to be investigationsal new drugs. The Investigational New Drug (IND) exemptions for these compounds were numbers 4041 and 14603, respectively, and were held by the Oak Ridge Institute for Science and Education (ORISE). Both compounds are now Food and Drug Administration approved for use in humans.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
No life-threatening toxicity has been associated with the administration of DTPA chelating agents. Among the side effects noted are nausea, vomiting, diarrhea, chills, fever, muscle cramps, and loss of the sense of smell. Usually these symptoms are mild and of short duration and do not persist after a break in the treatment regime. Risks of venipuncture include bruising and a remote risk of infection. The alternative to participation is to not participate and not receive the drug. No other effective treatment is known.
CONFIDENTIALITY
The identities of any subjects will be known to LBNL management and Health Services staff, but any public report will be by code numbers only. Subjects are told that scientists at ORISE and the Food and Drug Administration will have access to their records. Records of contamination and treatment are made available to the subject's personal physician upon request.
To date, this protocol has not been used.
This protocol was discontinued in April of 2005.
"Nu 99G8: The National Ovarian Cancer Early Detection Program - Molecular Cytogenetic Detection of Early Cancer"
Principal Investigator: Dr. Joe W. Gray, Lawrence Berkeley National Laboratory
Project started in: 2003
This project ended in fiscal year 2005.
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: 09/30/04
IRB approval number: 2004-2-13
Explanation of IRB approval:
This study is now complete and was discontinued in August of 2005.
Additional IRB approvals from other institutions:
Type of Review:
Full Board
Approving Institution: Northwestern University
Most recent approval: 12/12/03
IRB approval number: 0201-004
Explanation of additional approval:
The Northwestern University study has been completed, as has this study. All samples were obtained under a current IRB approved protocol.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 50
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
OBJECTIVES
To use comparative genomic techniques to develop improved methods for early cancer detection, particularly in women at risk for development of ovarian cancer.
METHODOLOGY
Residual tissue samples and patient record data are collected at Northwestern University under their fully-approved protocol. The samples are coded before being sent to Berkeley Lab for array comparative genomic hybridization and/or fluorescence in situ hybridization with gene-specific probes.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Berkeley Lab receives anonymous tissue samples and some limited data for analysis. The samples are residual from those normally taken from patients undergoing initial surgical evaluation or biopsy for purposes of their own treatment. No additional risks to subjects are incurred as a result of this project.
CONFIDENTIALITY
Samples are received at Berkeley Lab already coded, and Berkeley Lab has no access to the code key. Subjects are informed as part of the consent process at Northwestern that their samples may be used in other research projects.
UPDATE: After analyizing 50 tumor samples, this study is now complete and has been discontinued.
"Advanced Techniques in Latent Fingerprint Detection, Visualization and Analysis"
Principal Investigator: Dr. Michael C. Martin, Lawrence Berkeley National Laboratory
Project started in: 2003
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: 08/11/05
IRB approval number: 2003-8-9
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 10
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
CO-INVESTIGATORS: Wayne McKinney, PhD; Dale Perry, PhD; and T.J. Wilkinson
OBJECTIVE
To investigate the chemical nature of human latent fingerprints deposited by pre-pubescent and pubescent children as well as adults. The researchers hope to develop methods of latent fingerprint anlysis which will allow both the identification of latent prints from pre-pubescent children and some characterization of the fingerprint's depositor such as gender.
METHODOLOGY
Approximately 120 subjects will be recruited in three groups: adults, pubescent children (13 to 18 of age), and prepubescent children (under 13). Subjects will be recruited from among the Berkeley Lab staff and from private schools in the Berkeley area.
Subjects will be asked their age, gender, and whether or not they are taking any over-the-counter or prescription medications. Subjects will then be asked to give two latent fingerprints on gold or silver coated media after running their fingertips across their forehead, neck, or arm.
IONIZING RADIATION, RADIOACTIVE/CHEMICAL SUBSTANCES
None.
RISKS
The study is non-invasive and was found to be of minimal risk.
PRIVACY/CONFIDENTIALITY/CONSENT
Participation in the research may involve a slight risk of loss of confidentiality. However, all identities are treated as confidential. Names will never be associated with the fingerprint samples; the subjects' names will appear only on the consent forms. Fingerprints and data are labeled only with a randomly generated identification number, which is not linked to the list of names. After testing is complete, even the consent forms will be destroyed. Berkeley Lab participants are reminded that co-workers may learn of their status through simple observation.