Mr. Michael Chartock
MS 50A-4112
1 Cyclotron Road
Berkeley, CA 94720
Phone: 510-486-6669
Fax: 510-486-6866
Email: MAChartock@lbl.gov
Projects are approved by an IRB located at: Lawrence Berkeley National Laboratory.
The approving IRB operates under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
MPA number of the IRB: M- 1349-01
Number of Human Subjects Projects reported: 35
Project Identifier: LBNL-75-001-H02
Project Title:
Experimental Medicine Clinical
Principal Investigator:
Dr. Thomas F. Budinger
Project started in: 1975
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 19
Protocol/Subproject # 1
Protocol/Subproject Identifier: RMP 2
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 12, 1996
IRB Approval Number: CPHS 96-3-60
Number of Human Subjects who participated in this project/protocol during
04/12/95 - 04/12/96: 63
Type of Human Subjects Involvement:
OBJECTIVES
The objective of this study is the development and use of new technologies for the study of brain tumors. The focus is on 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 tumordiagnosis and staging programs.
METHODOLOGY
Subjects with confirmed brain tumors are given radio-tracer 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).
IRB Review:
Type of Review: Full Board
Most Recent Approval: June 07, 1996
IRB Approval Number: CPHS 96-6-104
Number of Human Subjects who participated in this project/protocol during
01/01/95 - 12/31/96: 20
Type of Human Subjects Involvement:
OBJECTIVES
To evaluate the efficacy of the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality in demonstrating epileptogenic foci in patients who are being evaluated for epileptic surgery. The current trial is aimed at determining: (1) whether high-resolution PET studies are better at detecting epileptogenic foci and localizing the cerebral cortex, and (2) the metabolism of epileptogenic foci. The benefit of this study to the subject and future individuals with epilepsy: specific therapeutic benefits to the subjects include selection of subjects who will be surgical candidates and localization of the epileptogenic focus for operation.
METHODOLOGY
Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm and another may be placed in the radial artery of the hand on the other arm. The venous catheter will be used to inject the radiotracer and the arterial catheter will be used to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. (In children, a second venous catheter will be used in place of the arterial catheter.) 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 between 60 and 120 minutes. Selected subjects may receive a second PET scan after surgery.
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); arterial catheter (bruising, pain, faintness, development of blood clot [1%]); radiation (equivalent to a back x-ray)
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 10, 1996
IRB Approval Number: CPHS 96-5-49
Number of Human Subjects who participated in this project/protocol during
05/10/95 - 05/10/96: 0
Type of Human Subjects Involvement:
OBJECTIVES
Hypoxia in human tumors is thought to represent a major obstacle to tumor control with radiation therapy. Reoxygenation of the tumor during therapy is thought to play an important role in determining the effectiveness of radiation treatment. This protocol is designed to evaluate the radiotracer fluorine-18 fluoromisonidazole, which preferentially labels hypoxic tissues. Specific aims include evaluating fluorine-18 fluoromisonidazole as a hypoxic cell tracer; determining the presence and fraction of hypoxic cells in human tumors and correlating this with tumor size and histology; quantifying the reoxygenation of tumor during the therapy selected by the personal oncologist; and comparing the response of hypoxic and non-hypoxic tumors to various therapies. Detection of hypoxic tumors may directly benefit subjects by giving their personal physicians more information on which to base therapy selection.
METHODOLOGY
Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm to inject the radiotracer. A second venous catheter is placed in the other arm to allow for periodic small blood withdrawals to confirm radiotracer clearance. 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 180 minutes. Subjects are scanned once before and once during or after tumor therapy.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, 0R CHEMICAL SUBSTANCES
Fluorine-18 Fluoromisodinazole
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray); discomfort of lying still.
IRB Review:
Type of Review: Full Board
Most Recent Approval: June 23, 1995
IRB Approval Number: CPHS 95-6-110
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 0
Type of Human Subjects Involvement:
"Cerebral Metabolism in Sickle Cell Disease: A PET Study"
OBJECTIVES
To combine positron emission tomography (PET)-Fluorine-18 fluorodeoxyglucose modality with neuropsychological techniques to observe abnormalities in cerebral function for subjects with Sickle Cell Disease (SCD). The study will involve subjects with ages ranging from 5 years to adulthood. This study will assess any differences in cerebral metabolism in subjects with neurological complications of SCD who undergo exchange transfusion to 50%, 10%, and 0% sickle cell hemoglobin (HBS) levels. Other goals include: evaluation of relationships between cognitive function and regional cerebral metabolism and the effects of pharmacological manipulation of fetal hemoglobin levels on regional cerebral metabolism. Benefits to the subject may include determination of significant neurological deficits and/or abnormalities. This study may benefit society by increasing our understanding of cerebral metabolism and neurological function to individuals with SCD.
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 90 minutes. Children who have difficulty remaining still during the scan may receive sedation, based on the judgment of their personal physician.
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).
THIS PROTOCOL WILL LIKELY BE DISCONTINUED DURING FY97; NO SUBJECTS STUDIED IN FY96. .
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 16, 1996
IRB Approval Number: CPHS 96-8-93
Number of Human Subjects who participated in this project/protocol during
08/16/95 - 08/16/96: 4
Type of Human Subjects Involvement:
OBJECTIVES
To determine the physiological threshold for perceived visual and neuromuscular sensations due to oscillating magnetic fields. The current trial is aimed at determining the threshold for neuromuscular stimulation and visual phenomenon induced by oscillating magnetic fields at varying frequencies; it also tests a hypothesis that oscillating magnetic fields below the threshold for stimulation of visual phosphenes will cause a change in melatonin release. Societal benefits may improve our understanding of disease and the ability to diagnose and treat future individuals.
METHODOLOGY
Subjects will either be involved in one of two protocols focusing on either (1) neuromuscular stimulation of the head, abdomen, and wrist using a whole body gradient coil for the head and abdomen and a smaller solenoid coil for the wrist or (2) on visual phosphene production and melatonin blood level changes using a hard coil.
For the neuromuscular stimulation protocol, a solenoid coil will be placed over the forearm which will be wrapped in foam pads in order to keep the forearm in the center of the coil. Pulses will be administered at different frequencies and threshold measurements will be made in 5 repetitions with no shielding followed by 5 repetitions with a cylindrical Faraday shield placed between the coil and the subject. The entire sequence will be repeated 5 times. The patient will then be placed in a whole body gradient coil positioned to achieve maximum field in the abdomen with the same sequence of repeated stimulations as for the forearm stimulation.
For the visual phosphene production/melatonin blood level change portion, a catheter will be placed in a vein to obtain blood samples at different stages of an experiment similar/identical to the first protocol.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Risks include: venous catheter (bruising, faintness)
IRB Review:
Type of Review: Full Board
Most Recent Approval: November 10, 1995
IRB Approval Number: CPHS 95-11-68
Number of Human Subjects who participated in this project/protocol during
11/10/94 - 11/10/95: 4
Type of Human Subjects Involvement:
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).
IRB Review:
Type of Review: Full Board
Most Recent Approval: October 11, 1996
IRB Approval Number: CPHS 96-10-89
Number of Human Subjects who participated in this project/protocol during
10/11/95 - 10/11/96: 0
Type of Human Subjects Involvement:
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).
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 10, 1996
IRB Approval Number: CPHS 96-5-54
Number of Human Subjects who participated in this project/protocol during
05/10/95 - 05/10/96: 3
Type of Human Subjects Involvement:
OBJECTIVES
To apply the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality to determine the neural mechanisms underlying attention in humans. The current trial uses normal adult subjects and those who have suffered from cerebral infarctions. PET imaging will be used while subjects perform an attentional task using a computer monitor. This study may benefit the subjects by allowing their physicians to use MRI and PET imaging to diagnose their illnesses. This study will benefit society by increasing our understanding of the brain in controlling visual attention. This may also assist people who have had strokes or other brain injuries.
METHODOLOGY
Subjects are positioned in a magnetic resonance imaging (MRI) scanner and may not move during the scan, which lasts approximately 30 minutes. Subjects are offered water before their PET scan begins. A catheter will be placed 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. After injection, the subjects will maintain visual fixation on the central fixation point of a video display monitor for 20 minutes. Subjects are then positioned in the PET scanner, for as long as 45 minutes, during which time they may not move. Subjects will be asked to participate in a second PET scan 1 to 4 weeks after the first.
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); arterial catheter (bruising, pain, faintness, development of blood clot [1%]); radiation (equivalent to back x-ray). MRI scan risk includes: discomfort associated with lying still in an enclosed space.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 16, 1996
IRB Approval Number: CPHS 96-8-94
Number of Human Subjects who participated in this project/protocol during
01/01/95 - 07/31/96: 7
Type of Human Subjects Involvement:
OBJECTIVES
To evaluate the efficacy of the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality in detecting the viability of 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)
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 08, 1995
IRB Approval Number: CPHS 95-12-49
Number of Human Subjects who participated in this project/protocol during
12/08/94 - 12/08/95: 3
Type 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).
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 16, 1996
IRB Approval Number: CPHS 96-2-79
Number of Human Subjects who participated in this project/protocol during
02/16/95 - 02/16/96: 11
Type of Human Subjects Involvement:
OBJECTIVES
To evaluate the efficacy of the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality in detecting the presence and activity of musculoskeletal tumors and monitoring response to chemotherapy. The tumor characteristics are defined by our in vivo glucose metabolic studies and the results of chemical tests on biopsies. The LBNL procedures are to be applied before the biopsy and at the end of chemotherapy prior to the definitive surgery; another scan may be given approximately two months following chemotherapy. 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 primary tumors of bone and soft tissue.
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.
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).
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 10, 1996
IRB Approval Number: CPHS 96-5-53
Number of Human Subjects who participated in this project/protocol during
05/10/95 - 05/10/96: 0
Type of Human Subjects Involvement:
OBJECTIVES
To determine the physiological threshold for disturbance of the serotonin/melatonin system due to oscillating magnetic fields. Specifically, this proposal is to determine the threshold for a change in nocturnal melatonin release by oscillating magnetic fields. The hypothesis being tested is that oscillating magnetic fields can stimulate the pineal in the same fashion as visible light.
METHODOLOGY
Human subjects will be involved in 4 or 5 separate studies (given at least 1 week apart) which will last overnight. A venous catheter will be placed for periodic blood sampling (3 cc) to determine blood melatonin levels throughout the night with a minimum of light (~100 lux) and in such a manner to disturb the subject as little as possible. At 1:00 AM the subject will be exposed to:
a) In the first study, 15 minutes of bright light (~2000 lux - equivalent to a brightly lit office);
b) In the control (second) study, the subject's head will be placed in a solenoidal coil but the magnetic field will not be turned on; or,
c) In the third through fifth studies, the subject's head will be placed in a solenoidal coil and exposed to a magnetic field at frequencies of 30, 60, and/or 1000 Hz.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
MRI scan risk includes: venous catheter (bruising, faintness); discomfort associated with lying still in an enclosed space.
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 10, 1996
IRB Approval Number: CPHS 96-5-55
Number of Human Subjects who participated in this project/protocol during
05/10/95 - 05/10/96: 6
Type of Human Subjects Involvement:
OBJECTIVES
To evaluate the efficacy of the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality in assessing primary and recurrent colonic and rectal carcinoma with or without metastases. The subject may benefit from the detection of the presence of metastasis or local recurrence using PET scans. Society may benefit from an improved technique for the diagnosis and management of future colorectal carcinoma patients.
METHODOLOGY
Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm. One catheter will be used to inject the radiotracer. A urinary bladder catheter will be placed by the physician performing the study in order to remove from the bladder any activity which might interfere with images of the rectum and sigmoid colon. 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 60 minutes. Every six months following these scans for an additional year, then annually for 2 more years, the subject may be asked to return for additional PET scans. Every 6 months for 4 years or until death, telephone interviews and clinical visits 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); urinary bladder catheter (discomfort, slight chance of urinary tract infection); radiation (equivalent to kidney x-ray).
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 16, 1996
IRB Approval Number: CPHS 96-8-95
Number of Human Subjects who participated in this project/protocol during
01/01/96 - 06/30/96: 9
Type of Human Subjects Involvement:
"Coronary Artery Disease Evaluation by Quantitative Perfusion Studies Using 13NH3 and..."
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 35mCi 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).
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 16, 1996
IRB Approval Number: CPHS 96-8-96
Number of Human Subjects who participated in this project/protocol during
01/01/96 - 06/30/96: 1
Type of Human Subjects Involvement:
"Coronary Artery Disease Evaluation by 13-Ammonia Perfusion and Deoxyglucose Uptake..."
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).
IRB Review:
Type of Review: Full Board
Most Recent Approval: June 07, 1996
IRB Approval Number: CPHS 96-6-63
Number of Human Subjects who participated in this project/protocol during
06/07/96 - 09/30/96: 0
Type of Human Subjects Involvement:
"PET Study of Lymphoma"
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 lymphoma as well as 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, 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 treatment and after chemotherapy but before radiotherapy. If significant metabolic uptake of the radiotracer is still detected during the second study (a possible indicator of remaining malignancy) then a third scan will be used after completion of radiation 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).
IRB Review:
Type of Review: Full Board
Most Recent Approval: June 07, 1996
IRB Approval Number: CPHS 96-6-62
Number of Human Subjects who participated in this project/protocol during
06/07/96 - 09/30/96: 0
Type of Human Subjects Involvement:
"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).
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 16, 1996
IRB Approval Number: CPHS 96-8-89
Number of Human Subjects who participated in this project/protocol during
08/16/96 - 09/30/96: 0
Type of Human Subjects Involvement:
"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).
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 16, 1996
IRB Approval Number: CPHS 96-8-91
Number of Human Subjects who participated in this project/protocol during
08/16/96 - 09/30/96: 0
Type of Human Subjects Involvement:
"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 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 indicate 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).
Project Identifier: LBNL-75-102-H01
Project Title:
Treatment of Cancer with Heavy Charged Particles
Principal Investigator:
Dr. Joseph R. Castro
Project started in: 1975
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Assignment #CA-19138
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 12, 1996
IRB Approval Number: 96-4-56
Number of Human Subjects who participated in this project/protocol during
04/12/95 - 04/12/96: 670
Type of Human Subjects Involvement:
OBJECTIVES
To evaluate the effectiveness of cancer treatment 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 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.
Project Identifier: LBNL-77-057-H02
Project Title:
Cell and Molecular Biology of Lipoprotein Metabolism
Principal Investigator:
Dr. Trudy M. Forte
Project started in: 1977
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
This training grant supports post-doctoral students who may participate in human research, but does not support research directly.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 17, 1996
IRB Approval Number: 96-4-62
Number of Human Subjects who participated in this project/protocol during
04/17/95 - 04/17/96: 0
Type 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 use of surplus blood collected for another project. No additional risks to subjects are incurred as a result of this grant.
Project Identifier: LBNL-79-106-H02
Project Title:
Lipoprotein and Atherogenesis in Transgenic Animals (Formerly: Metabolic & Genetic Origins of Lipoprotein Subclasses)
Principal Investigator:
Dr. Ronald M. Krauss
Project started in: 1979
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 7
Protocol/Subproject # 1
Protocol/Subproject Identifier: CRC Coll #1
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 10, 1996
IRB Approval Number: 96-5-86
Number of Human Subjects who participated in this project/protocol during
05/10/95 - 05/10/96: 25
Type of Human Subjects Involvement:
TITLE: Metabolic and Kinetic Basis of LDL Subclass Patterns and Effects of High-Carbohydrate Diet (collaborative study with Hellerstein of University of California, San Francisco)
OBJECTIVES
The objective of this study is to understand where the different density subclasses of lipoprotein come from and why their patterns differ among subjects with different risks for atherogenesis. With better understanding of the underlying principles, better diagnostic tools may be formed for the treatment of persons with lipoprotein disorders.
METHODOLOGY
Prospective subjects are classified by lipid subclass pattern; if they meet certain criteria, they are assigned to various dietary studies. Blood samples and tracer studies are used to assess subject's response to varying diet. Dietary studies, tracer studies, and blood drains take place at the collaborating site and are reviewed and approved by that Institutional Review Board.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Human subject involvement is limited to the analysis of serum samples collected at another site; no additional risk to subjects is incurred by this analysis.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 19, 1994
IRB Approval Number: 94-8-108
Number of Human Subjects who participated in this project/protocol during
08/20/94 - 10/19/95: 0
Type of Human Subjects Involvement:
TITLE: Cellular Origins of Apoprotein-Specific HDL Subclasses (Principal Investigator, T. Forte)
OBJECTIVES
The objective is to define the biochemical abnormalities in the Smith-Lemli-Opitz syndrome, a recessively inherited metabolic disorder associated with an inability of the affected subject to synthesize cholesterol. It is hoped that more accurate, specific biochemical characterization of the disorder will permit formulation of treatments and case management plans.
METHODOLOGY
Lipoproteins in the 1-2 ml samples are characterized via electron microscopy and gel electrophoresis.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Human involvement is limited to use of 1-2 ml plasma samples collected by another researcher.
THIS PROJECT WAS DISCONTINUED OCTOBER 1995.
IRB Review:
Type of Review: Full Board
Most Recent Approval: March 15, 1996
IRB Approval Number: 96-3-10
Number of Human Subjects who participated in this project/protocol during
03/15/95 - 03/15/96: 427
Type of Human Subjects Involvement:
TITLE: Genetic Analysis of Five HDL Subclasses in Family Sets (Principal Investigator, P. Williams)
To apply specific graphic and statistical analysis in an examination of high-density lipoprotein subclass distributions in related individuals.
The data set under analysis was previously collected as part of the study of familial lipoprotein patterns. At the time of the data collection the statistical and mathematics ability to examine HDL subclasses did not exist. Data from the same population of 427 continues to be examined; no new subjects or additional risks are involved.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 16, 1996
IRB Approval Number: 96-2-101
Number of Human Subjects who participated in this project/protocol during
02/16/95 - 02/16/96: 4
Type of Human Subjects Involvement:
TITLE: Blood Donations for Transgenic Studies (Formerly "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. In June, 1996, this protocol was amended to include the goal of using some of these blood samples as sources of genes for transgenic animals.
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). Subjects must sign a separate and specific consent form before their samples can be used for transgenic research.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 16, 1996
IRB Approval Number: 96-2-101
Number of Human Subjects who participated in this project/protocol during
02/16/95 - 02/16/96: 453
Type 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 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).
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 17, 1995
IRB Approval Number: 95-4-85
Number of Human Subjects who participated in this project/protocol during
04/01/95 - 01/30/96: 0
Type of Human Subjects Involvement:
TITLE: Postprandial Chylomicron Clearance After an Intravenous Fat Load
NOTE: This protocol was discontinued in January, 1996.
OBJECTIVES
The objective of this study is to examine the mechanisms underlying changes in lipoprotein and chylomicron levels. This will aid in the formation of better diagnostic and treatment tools for conditions involving atherogenesis, the development of arterial plaques.
METHODOLOGY
Control subjects and individuals with specific blood plasma lipoprotein profiles will have their chylomicron clearance rate determined by consuming a high-fat meal after an infusion of synthetically produced chylomicron particles. Blood is then drawn by common clinical venipuncture and analyzed.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Intravenous administration of a solution of artificial chylomicron particles. A standardized high-fat milkshake will be taken orally.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Subjects will include normal controls and those with any of three inherited blood lipid abnormalities. Subjects on lipid lowering medication will be asked to abstain for six weeks prior, at no significant risk to the patient due to the short duration. All will be injected with a solution of laboratory-created chylomicron particles and given a high-fat milkshake to consume; the clearance rate will be determined by sequentially sampling blood over the following 90 minutes. Both the chylomicrons infusion and venipuncture carry a remote risk of infection.
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 08, 1996
IRB Approval Number: 96-2-102
Number of Human Subjects who participated in this project/protocol during
05/08/95 - 05/08/96: 0
Type of Human Subjects Involvement:
TITLE: Effects of a High-Fat Meal on the Lipid Composition of Lipoprotein Subfractions in Pattern A and Pattern B Subjects
OBJECTIVES
The objective of this study is to investigate possible differences in the postprandial lipemia of subjects with Type A and Type B lipoprotein profiles and, in turn, examine that relationship with respect to the incidence of coronary arterial disease (CAD). Type B subjects, characterized by the predominance of small, dense low-density lipoprotein particles, increased triglyceride levels, and reductions in high-density lipoprotein have a three-fold increased risk of myocardial infarction, but little is known of the role of different responses following eating. This information will aid in the formation of better diagnostic tools and treatment regimes for people with increased CAD risk.
METHODOLOGY
Subjects in this study receive a high-fat meal (milkshake) followed by a collection of blood by routine venipuncture. The results of the blood lipid analyses are then evaluated in light of the subject's clinical and familial history of CAD.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
A standardized high-fat milkshake will be taken orally.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Subjects will have blood drawn for the Type A/B screening. On the day of the study, the subjects, who have fasted 12 hours, have a blood sample taken, then consume a high-fat milkshake. Four hours afterwards, blood will be drawn and a second milkshake consumed. Blood will be drawn again four hours later. The blood drawing process, via venipuncture, carries a small risk of bruising and a remote risk of infection.
Project Identifier: LBNL-79-108-H01
Project Title:
Characterization of Human Mammary Cells
Principal Investigator:
Dr. Martha R. Stampfer
Project started in: 1979
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Field Task Proposal title: "Rapid Transformation Assay" Account #4417
Assignment #CA24844
Total Funding: $516,253
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Protocol/Subproject # 1
Protocol/Subproject Identifier: Stampfer 1
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 10, 1996
IRB Approval Number: 96-5-48
Number of Human Subjects who participated in this project/protocol during
05/10/95 - 05/10/96: 0
Type of Human Subjects Involvement:
This research is concerned with growth control of human breast cells and relationship of differentiation with transformation.
Human milk contains a small number of living cells which 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.
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 10, 1996
IRB Approval Number: 96-5-48
Number of Human Subjects who participated in this project/protocol during
05/10/95 - 05/10/96: 1
Type 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.
Project Identifier: LBNL-80-001-H01
Project Title:
Myocardial Flow, Function, and Metabolism by PET & MRI (Cardiovascular Flow and Metabolism)
Principal Investigator:
Dr. Thomas F. Budinger
Project started in: 1980
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Project continues to be funded by National Heart, Lung and Blood Institute (NHLBI). No funding is reported because no funds were spent on human subjects in FY 1996.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 16, 1996
IRB Approval Number: 96-8-100
Number of Human Subjects who participated in this project/protocol during
08/16/95 - 08/16/96: 0
Type of Human Subjects Involvement:
OBJECTIVES
To demonstrate the value of quantitative information on specific coronary flow fields in patient diagnosis and management. To determine the influence of drugs and ischemic events on the sensitivity of rubidium as a flow marker to be sure that the myocyte and capillary membranes do not have an extraction markedly different from that of normal tissues at equivalent flow values. Secondly, we wish to determine how well we can actually quantitate flow by kinetic analysis for the time course of activity in the ventricle blood pool and regions of the myocardium using non-invasive positron emission tomography (PET) methods developed during the last 10 years in our laboratory. Societal benefits from this research may include earlier detection of coronary artery disease in the future.
METHODOLOGY
Two injections of 60 mCi are planned with allowance for a 3rd injection if necessary. Patients will receive constant monitoring of blood pressure and EKG while under doses of vasodilators, adenosine and dipyridamole. Aminophylline will be used to reverse the effects of dipyridamole, if necessary. Before and after the use of the vasodilators, PET scan imaging studies will be done.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Rubidium-82 as a radiotracer. Vasodilators adenosine and dipyridamole.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risks include: venous catheter (bruising, faintness); radiation (equivalent to back x-ray). The risk of using vasodilators is that common to their clinical use as diagnostic aids (temporarily lowered blood pressure possibly causing dizziness, flushing, headaches, and/or mild chest pain similar to angina).
Project Identifier: LBNL-82-001-H04
Project Title:
Quantitative Cardiovascular Research
Principal Investigator:
Dr. Thomas F. Budinger
Project started in: 1982
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
This training grant supports post-doctoral students who may participate in human research, but does not support research directly.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 16, 1996
IRB Approval Number: CPHS 96-8-101
Number of Human Subjects who participated in this project/protocol during
08/16/95 - 08/16/96: 0
Type 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 Protocol (RMP) 1 and RMP 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.
Project Identifier: LBNL-84-001-H03
Project Title:
Cerebral Chemical Patterns in Alzheimer's Disease
Principal Investigator:
Dr. Thomas F. Budinger
Project started in: 1984
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Protocol/Subproject # 1
Protocol/Subproject Identifier: RMP 24
IRB Review:
Type of Review: Full Board
Most Recent Approval: June 07, 1996
IRB Approval Number: CPHS 96-6-103
Number of Human Subjects who participated in this project/protocol during
06/07/95 - 06/07/96: 0
Type of Human Subjects Involvement:
OBJECTIVES
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. 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 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.
SPECIAL NOTE
The number of subjects participating in this protocol is reported under "Longitudinal SPECT and PET Studies of Dementia" (LBNL-88-073-H02). These subjects were not studied separately for "Cerebral Chemical Patterns in Alzheimer's Disease", therefore, the number of subjects reported under this project is zero to prevent double counting.
IRB Review:
Type of Review: Full Board
Most Recent Approval: June 07, 1996
IRB Approval Number: CPHS 96-6-106
Number of Human Subjects who participated in this project/protocol during
06/07/95 - 06/07/96: 0
Type of Human Subjects Involvement:
OBJECTIVES
To evaluate the efficacy of the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality in combination with neuropsychological techniques to assess cerebral function abnormalities in subjects with Alcohol Dementia (AlcD) and Korsakoff's syndrome (KS). The current trial is aimed at defining brain regions which show impaired function in these subjects. Societal benefits may include a better understanding of the chronic effects of alcohol on cerebral function in different alcohol-induced syndromes.
METHODOLOGY
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 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 120 minutes. Subsequently, the subjects may be placed in an MRI scanner for 2 scans. Age matched controls are also studied.
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, lodocaine is injected to provide local anesthesia prior to placing the catheter.
MRI scan risk includes: discomfort associated with lying still in an enclosed space.
SPECIAL NOTE
The number of subjects participating in this protocol is reported under "Alcohol and Memory" (LBNL-91-073-H01). These subjects were not studied separately for the "Cerebral Chemical Patterns in Alzheimer's Disease", therefore, the number of subjects reported under this project is zero to prevent counting the subjects twice.
Project Identifier: LBNL-84-115-H01
Project Title:
Lighting Technology
Principal Investigator:
Dr. Francis Rubinstein
Project started in: 1984
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Grant Number 4748
Project does not involve use of multiple protocols/subprojects.
Protocol/Subproject Identifier: 95-9-53
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 13, 1996
IRB Approval Number: 96-9-51
Number of Human Subjects who participated in this project/protocol during
09/13/95 - 09/13/96: 65
Type of Human Subjects Involvement:
OBJECTIVES
The objective of this study is to examine psychophysical effects of interior lighting, to gain a better understanding of the fundamental mechanisms of the effects, and to estimate the consequences for lighting-design practice. A particular interest within this study is the effect of video display terminal use under the interior lighting conditions being studied.
METHODOLOGY
Separate studies utilizing various methods will be performed to answer several research questions. These studies will include various lamps and lighting conditions, but none that emit harmful levels of ultraviolet light. Subjects will be exposed to light of varying intensity and/or spectral composition, during which visual and mental tasks will be administered. Some sections of the study include defocusing.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
There are no known long-term risks to subjects exposed to acute conditions of interior lighting with the lamps and intensities used. The defocusing procedure may cause mild discomfort and headache similar to that experienced during a routine eye exam. Even without this procedure some patients may experience some "visual fatigue" or other symptoms from a visual task. Subjects have the opportunity to end their participation, if they wish, at any time.
Project Identifier: LBNL-88-073-H02
Project Title:
Longitudinal SPECT & PET Studies of Dementia
Principal Investigator:
Dr. William J. Jagust
Project started in: 1988
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Protocol/Subproject # 1
Protocol/Subproject Identifier: RMP 24
IRB Review:
Type of Review: Full Board
Most Recent Approval: June 07, 1996
IRB Approval Number: 96-6-103
Number of Human Subjects who participated in this project/protocol during
06/07/95 - 06/07/96: 29
Type of Human Subjects Involvement:
OBJECTIVES
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. Develop new radiotracers 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 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.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 16, 1996
IRB Approval Number: CPHS 96-2-81
Number of Human Subjects who participated in this project/protocol during
02/16/95 - 02/16/96: 13
Type of Human Subjects Involvement:
OBJECTIVES
To clarify the mechanisms through which subcortical lacunar infarction may lead to cognitive impairment and dementia using magnetic resonance imaging (MRI) to quantify features of lacunae, high resolution positron emission tomography (PET) to measure cerebral metabolic rates for glucose (CMRglc) and neuropsychological tests. Benefits to the subjects may include the diagnostic utility of these imaging techniques, as well as the neuropsychological testing. Societal benefits may include a better understanding of dementia and cerebrovascular disease.
METHODOLOGY
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 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 approximately 90 minutes. Subsequently, the subjects may be placed in an MRI scanner for 2 scans totaling less than 30 minutes. Subjects will also undergo neuropsychological testing at the University of California at Davis, Northern California Alzheimer's Disease Center.
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.
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
Project started in: 1988
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Explanation:
Funding completed for study
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 16, 1996
IRB Approval Number: 96-2-82
Number of Human Subjects who participated in this project/protocol during
02/16/95 - 02/16/96: 400
Type 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 total living cohort numbers approximately 2,100; in FY 95-96, emphasis is being placed on recontacting the approximately 400 surviving female members of the cohort. 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.
Project Identifier: LBNL-89