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 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 18
Protocol/Subproject # 1
Protocol/Subproject Identifier: RMP 2
IRB Review:
Type of Review: Full Board
Most Recent Approval: March 19, 1998
IRB Approval Number: 98-3-102
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 10
Type of Human Subjects Involvement:
TITLE: Human Tumor Evaluation by Fluorodeoxyglucose and PET
OBJECTIVES
The objective of this study is the development and use of new technologies for the study of brain tumors. The focus is on the development of advanced emission tomography imaging modalities, as well as further development of magnetic resonance imaging techniques. This study hopes to lead in the development of effective brain tumor diagnosis and staging programs.
METHODOLOGY
Subjects with confirmed brain tumors are given radiotracer enhanced positron emission tomography (PET) scans before and 18 months after radiation therapy. As part of this procedure, patients are given both a venous and an arterial catheter for the administration of the radiotracer [fluorodeoxyglucose (FDG-18)]. Children receive a second venous catheter instead of an arterial catheter.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Fluorine-18 Fluorodeoxyglucose (FDG-18) is used to enhance the PET scans.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risks include: venous catheter (bruising, faintness); arterial catheter (bruising, pain, faintness, development of a blot clot [1%]); radiation (equivalent to back x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and MRI are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
IRB Review:
Type of Review: Full Board
Most Recent Approval: June 06, 1997
IRB Approval Number: 97-6-102
Number of Human Subjects who participated in this project/protocol during
10/01/97 - 04/28/98: 4
Period of FY98 during which protocol was full approved.
Type of Human Subjects Involvement:
TITLE: Demonstration of Epileptogenic Foci with FDG-PET
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)
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and/or MRI are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
THIS PROTOCOL WAS DISCONTINUED APRIL 28, 1998.
IRB Review:
Type of Review: Full Board
Most Recent Approval: November 07, 1997
IRB Approval Number: 97-11-32
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 0
Type of Human Subjects Involvement:
TITLE: PET Study of Prostate Cancer
OBJECTIVES
To evaluate the efficacy of the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality in detecting the presence and size of primary and metastatic prostate cancer. The LBNL procedures are to be applied twice, once during the initial visit, then two to four months following this initial scan. The subject may benefit from the detection of the presence of metastasis. Society may benefit from an improved technique for the diagnosis and management of future prostate cancer patients.
METHODOLOGY
A urinary bladder catheter will be placed to remove from the bladder any activity which might interfere with the image of the prostate. Then, a catheter will be placed in a vein in one arm to inject the radiotracer. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last as long as 120 minutes. A second scan will be performed two to four months following the initial scan to evaluate progression of the disease for subjects off therapy or therapeutic response for subjects who are receiving therapy. The subject will be followed for 3 years to evaluate the outcome of therapy with the study's analyses.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Fluorine-18 Fluorodeoxyglucose (FDG-18)
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: urinary catheter (discomfort, slight chance of urinary tract infection); venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and/or MRI are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
IRB Review:
Type of Review: Full Board
Most Recent Approval: October 10, 1997
IRB Approval Number: 97-10-74
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 1
Type of Human Subjects Involvement:
TITLE: PET Study of Breast Cancer
OBJECTIVES
To evaluate the efficacy of the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality in detecting the presence and size of primary and metastatic breast cancer. The LBNL procedures are to be applied twice, once during the initial visit, then two to four months following this initial scan. The subject may benefit from the detection of the presence of metastasis. Society may benefit from an improved technique for the diagnosis and management of future breast cancer patients.
METHODOLOGY
A catheter will be placed in a vein in one arm to inject the radiotracer. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last as long as 120 minutes. A second scan will be performed two to four months following the initial scan to evaluate progression of the disease for subjects off therapy or therapeutic response for subjects who are receiving therapy.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Fluorine-18 Fluorodeoxyglucose (FDG-18)
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and/or MRI are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
IRB Review:
Type of Review: Full Board
Most Recent Approval: June 06, 1997
IRB Approval Number: 97-6-99
Number of Human Subjects who participated in this project/protocol during
10/01/97 - 04/06/98: 0
Period of FY98 during which protocol was fully approved.
Type of Human Subjects Involvement:
TITLE: Neural Mechanisms for Inhibiting Visual Information
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.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and/or MRI are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
THIS PROTOCOL WAS DISCONTINUED APRIL 6, 1998
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 28, 1998
IRB Approval Number: 98-8-119
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 0
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 the heart muscle. The current trial is aimed at determining which of the patients with a negative diagnosis by a thallium perfusion study have a positive diagnosis for reversible disease by FDG. The benefit of this study to the subject and future individuals with damaged heart muscle is reversibility.
METHODOLOGY
Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm to inject the radiotracer. After a half-hour uptake phase, subjects are asked to empty their bladder to keep the radiation exposure to the bladder as low as possible. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last as long as 120 minutes.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Fluorine-18 Fluorodeoxyglucose.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risks include: venous catheter (bruising, faintness); radiation (equivalent to a back x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and/or MRI are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 05, 1997
IRB Approval Number: 97-12-76
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 2
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).
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.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 14, 1997
IRB Approval Number: 97-2-38
Number of Human Subjects who participated in this project/protocol during
10/01/97 - 02/13/98: 0
Period of FY98 during which protocol was fully approved.
Type of Human Subjects Involvement:
TITLE: Musculoskeletal Tumors: Assessment Using Positron Emission Tomography
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).
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. Children are eligible to participate in this project; assent of a child is required and documented by signature in addition to the written consent of the parent/legal guardian.
THIS PROTOCOL WAS DISCONTINUED IN FEBRUARY, 1998
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 09, 1997
IRB Approval Number: 97-5-56
Number of Human Subjects who participated in this project/protocol during
10/01/97 - 03/03/98: 0
Period of FY98 during which protocol was fully approved.
Type of Human Subjects Involvement:
TITLE: Determination of Thresholds for Changes in Nocturnal Melatonin Release Induced by Oscillating Magnetic Fields
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.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Subjects are reminded that research records are not immune to subpoena.
THIS PROTOCOL WAS DISCONTINUED IN MARCH, 1998.
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 09, 1997
IRB Approval Number: 97-5-97
Number of Human Subjects who participated in this project/protocol during
10/01/97 - 03/31/98: 0
Period of FY98 during which protocol was fully approved.
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).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and/or MRI are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
THIS PROTOCOL WAS DISCONTINUED IN MARCH, 1998.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 15, 1997
IRB Approval Number: 97-4-79
Number of Human Subjects who participated in this project/protocol during
10/01/97 - 03/31/98: 0
Period of FY98 during which protocol was fully approved.
Type of Human Subjects Involvement:
TITLE: In Vivo Sodium Content by MRI
OBJECTIVES
To demonstrate the utility of a new technique called 'short and long T2 magnetic resonance imaging' for making an in vivo evaluation of the sodium concentration in human tissues. If the sodium concentration can be accurately determined in vivo it may be useful as a diagnostic for living tissue.
METHODOLOGY
A small number of human subjects will have their arms imaged twice, once by conventional MRI and once by the sodium MRI which uses a different pulse frequency.
IONIZING RADIATION
None.
INVOLVEMENT OF HUMAN SUBJECTS AND RISKS
There are no known risks to magnetic resonance imaging.
CONFIDENTIALITY
The identities of the subjects will be known as they will be recruited from the senior scientists in the research lab. Any public report of the data will be by code numbers only.
THIS PROTOCOL WAS DISCONTINUED IN MARCH, 1998.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 28, 1998
IRB Approval Number: 98-8-125
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 0
Type of Human Subjects Involvement:
TITLE: Coronary Artery Disease Evaluation by Quantitative Perfusion Studies Using 13NH3 and PET
OBJECTIVES
The purpose of this project is to develop noninvasive, rapid, and economical methods for the evaluation of cardiac ischemia. This protocol will evaluate the clinical utility of quantitative heart perfusion data obtained with the radiotracer 13-nitrogen ammonia (13NH3) and Positron Emission Tomography (PET). The PET scan may provide information that could benefit the patient in his/her overall therapy management, but such a benefit is not assured. Society would benefit from improved and more economical diagnostic tests.
METHODOLOGY
A catheter will be placed in a vein in one arm to inject the radiotracers and to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. A blood glucose test will be performed, and patients with blood sugars less that 120 mg% will receive oral glucose loading. After positioning the subject in the PET scanner, a transmission scan without radiotracer will be done to allow corrections of the emission data. Next the first 35 mCi dose of 13NH3 is injected and a resting PET scan is taken. Between 30 and 40 minutes after the initial tracer injection, dipyridamole will be infused intravenously. The second 13NH3 injection is given about 4 minutes after the perfusion is completed and the final PET scan begins shortly thereafter. Subjects may not move during the scans. The total procedure should take about 120 minutes.
RADIATION/CHEMICAL SUBSTANCES
13-nitrogen ammonia; dipyridamole
INVOLVEMENT OF HUMAN SUBJECTS
Risks include: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray); and the routine risks associated with any clinical use of dipyridamole (occasional severe chest pain, severe hypotension, respiratory distress, and vomiting or nausea; rarely, symptoms of myocardial ischemia requiring the use of aminophylline to reverse the effect; very rarely, heart attack or death).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET scans are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 28, 1998
IRB Approval Number: 98-8-121
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 0
Type of Human Subjects Involvement:
TITLE: Coronary Artery Disease Evaluation by 13-Ammonia Perfusion and Deoxyglucose Uptake Measured by PET and Three-Dimensional MR Myocardial Tagging
OBJECTIVES
The purpose of this project is to develop noninvasive, rapid, and economical methods for the evaluation of myocardial perfusion and metabolism. This protocol will compare magnetic resonance imaging (MRI) strain data from rest and low dose dobutamine stress conditions to PET 13-ammonia/ 18F-fluorodeoxyglucose (FDG) studies to determine which is the superior technique. The PET scan may provide information that could benefit the patient in his/her overall therapy management, but such a benefit is not assured. Society would benefit from improved and more economical diagnostic tests.
METHODOLOGY
MRI: The standard medical procedure for myocardial tagging image will be used. Subjects will discontinue beta-blocker medications 48 hours before the procedure (with the permission of their personal physician/cardiologist). A venous catheter will be placed and heart rate and blood pressure monitors attached. After a resting MRI, dobutamine will be administered as a cardiac stressor. Drugs to counteract the effect of the dobutamine, if needed, will be on hand.
PET: Patients will fast the night before scanning. Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm to inject the radiotracers and to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. First the 13-ammonia scan is performed. Subjects are then allowed to void if necessary. Then a transmission scan without radiotracer is performed to allow corrections of the emission data. Lastly, the 18-FDG study is done. Subjects may not move during the scans. The total procedure should take about 120 minutes.
RADIATION/CHEMICAL SUBSTANCES
MRI: dobutamine
PET: Fluorine-18 fluorodeoxyglucose; nitrogen-13 ammonia
INVOLVEMENT OF HUMAN SUBJECTS
Each of the subjects will have two MRI studies but most subjects will have only a single 13-ammonia vs 18-FDG uptake PET study.
MRI risks include: venous catheter (bruising, faintness); the discomfort of lying still in an enclosed space for a long period of time; the rare chance of an allergic reaction to dobutamine; the possibility of discomfort associated with discontinuing medication 48 hours prior to the study; and the rare possibility (as with any stress test) of arrythmia, heart attack, or death.
PET scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and or MRI are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 15, 1997
IRB Approval Number: 97-8-145
Number of Human Subjects who participated in this project/protocol during
10/01/97 - 07/28/98: 1
Period of FY98 during which protocol was fully approved.
Type of Human Subjects Involvement:
TITLE: 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 may 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).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET scans are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
THIS PROTOCOL WAS DISCONTINUED IN JULY, 1998.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 28, 1998
IRB Approval Number: 98-8-118
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 0
Type of Human Subjects Involvement:
TITLE: PET Transmission Studies
OBJECTIVE
The goal of this project is to produce better quality Positron Emission Tomography (PET) images with higher resolution. The researchers will examine how PET technology and analysis algorithms can compensate for the slight movements made by the chest during normal breathing. Subjects will receive no direct benefit, but society may benefit from improved PET diagnostic techniques.
METHODOLOGY
Subjects will receive a single PET scan of 1 - 2 hours without catheterization or radiotracer.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: the discomfort of lying still for a prolonged period; radiation (equivalent to less than 1/20th of a back x-ray). Note that no radiotracer is given.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Subjects are reminded that research records are not immune to subpoena.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 28, 1998
IRB Approval Number: 98-8-123
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 9
Type of Human Subjects Involvement:
TITLE: Head and Neck Tumor Evaluation by Fluorodeoxyglucose and PET
OBJECTIVES
To evaluate the efficacy of the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality in detecting the presence and size of primary and metastatic cancer involving the head and neck. The subject may benefit from pre- and post-therapy PET scans in diagnosing and monitoring the status of his/her illness. Society may benefit from an improved technique for the diagnosis, prognosis and management of future patients with head and neck tumors.
METHODOLOGY
Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm to inject the radiotracer and to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. After a half-hour uptake phase, subjects are asked to empty their bladder to keep the radiation exposure to the bladder as low as possible. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last as long as 120 minutes.
The LBNL procedures are to be applied before and after treatment. A third PET study may be performed if the first or second study suffers a correctable problem (e.g., instrument failure) and the study is deemed important to the patient, or if a third study is indicated to evaluate the long-term outcome of therapy.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Fluorine-18 Fluorodeoxyglucose (FDG-18)
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to back x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET scan(s) are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 28, 1998
IRB Approval Number: 98-8-120
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 3
Type of Human Subjects Involvement:
TITLE: Melanoma Tumor Evaluation by Fluorodeoxyglucose and PET
OBJECTIVES
To evaluate the efficacy of the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality in detecting the presence and size of primary and metastatic melanoma as well as to follow-up to the course of treatment. The subject may benefit from pre- and post-therapy PET scans in diagnosing and monitoring the status of his/her illness. Society may benefit from an improved technique for the diagnosis and management of future patients with lymphoma.
METHODOLOGY
Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm to inject the radiotracer and to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. After a half-hour uptake phase and after the first hour of scanning, subjects are asked to empty their bladder to keep the radiation exposure to the bladder as low as possible. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Except as noted above, subjects may not move during the scan, which may last as long as 3 hours.
The LBNL procedures are to be applied before and after treatment. A third PET study may be performed if the first or second study suffers a correctable failure (e.g., instrument failure) and the study is deemed important to the patient, or if a third study is indicated to evaluate the long-term outcome of therapy.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Fluorine-18 Fluorodeoxyglucose (FDG-18)
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to back x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET scan(s) are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 05, 1997
IRB Approval Number: 97-12-53
Number of Human Subjects who participated in this project/protocol during
12/05/98 - 09/30/98: 1
Initial approval period falling within FY 1998.
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
TITLE: Coronary Artery Disease Evaluation by Quantitative Perfusion Studies Using Rest/Stress 62-Cu PTSM and Positron Emission Tomography (PET) vs. Rest/Stress 201 T1 or 99mTc - Sestamibi Single Photon Emission Computed Tomography (SPECT)
OBJECTIVES
The purpose of this project is to develop noninvasive, rapid, and economical methods for the evaluation of cardiac ischemia. This protocol will compare the clinical utility of quantitative heart perfusion data obtained with the radiotracer 62-copper pyruvaldehyde Bis (N(4)-methyl) thiosemicarbazone (62-Cu PTSM) and PET scanning to SPECT scans done with Food and Drug Administration approved perfusion tracers. The PET scan may provide information that could benefit the patient in his/her overall therapy management, but such a benefit is not assured. Society would benefit from improved and more economical diagnostic tests.
METHODOLOGY
Subjects with suspected stable ischemic coronary artery disease who either have undergone or are scheduled to undergo coronary angiography and a SPECT myocardial perfusion study will be recruited for this protocol. Neither the angiography nor the SPECT scan will be performed as part of this study.
For the PET scan, a catheter will be placed in a vein in one arm to inject the radiotracers and to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. After positioning the subject in the PET scanner, a transmission scan without radiotracer will be done to allow corrections of the emission data. Next the first 30 mCi dose of 62-Cu PTSM is injected and a resting PET scan is taken. Between 40 and 50 minutes after the initial tracer injection, hypotension will be induced by adenosine or dipyridamole injection or by cold pressor stimulation (immersion of a hand in ice water). The second 62-Cu PTSM injection is given about 4 minutes after the infusion of adenosine or dipyridamole (or 30 seconds after cold pressor stimulation) is completed and the final PET scan begins shortly thereafter. Subjects may not move during the scans. The effect of dipyridamole will be reversed by the use of aminophylline; the effect of cold pressor stimulation by the use of nitroglycerine if needed. The total procedure should take about 120 minutes.
RADIATION/CHEMICAL SUBSTANCES
62-Cu PTSM; adenosine or dipyridamole and aminophylline or possibly nitroglycerine
INVOLVEMENT OF HUMAN SUBJECTS
Risks include: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray); the routine risks associated with any clinical use of adenosine, dipyridamole or cold pressor stimulation (occasional severe chest pain, severe hypotension, respiratory distress, and vomiting or nausea; rarely, symptoms of myocardial ischemia requiring the use of aminophylline to reverse the effect; very rarely, heart attack or death), and the discomfort associated with lying still for an extended period of time.
Most subjects will receive only one PET scan. Up to five subjects will receive a second 62-Cu PTSM PET study.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET scans are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
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 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Assignment #CA-19138
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 08, 1998
IRB Approval Number: 98-5-91
Number of Human Subjects who participated in this project/protocol during
05/08/97 - 05/08/98: 600
Type of Human Subjects Involvement:
OBJECTIVES
To evaluate the effectiveness of cancer treatment under multiple protocols with heavy charged particle beams. The LBNL treatment phase of the project was discontinued after closure of the Bevalac in 1992; currently the project has been extended to allow follow-up of patients already treated. Societal benefits may include a better understanding of treatment options for individuals with cancer and a better understanding of the associated risks and side effects.
METHODOLOGY
Human subjects involvement includes follow-up of subjects already treated. The subject pool includes those treated at LBNL and at other Northern California Oncology Group sites. During 1994, a new study for the treatment of ocular melanoma was begun at the University of California at Davis (UCD) Crocker Cyclotron; subjects treated as part of that project will also be followed under this study. Follow-up includes gathering data from existing records as well as from post-treatment specific examinations.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Treatment of ocular melanoma patients with protons using the Crocker Cyclotron at UCD.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
No additional risk accrues to the subjects from participation in the follow-up study.
CONFIDENTIALITY
Patient results are published only in the aggregate.
Project Identifier: LBNL-77-057-H02
Project Title:
Studies of Lipoproteins and Lipid Protein Interactions
Principal Investigator:
Dr. Edward Rubin
Project started in: 1977
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
This training grant supports post-doctoral students who may participate in human research, but does not support research directly.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: January 16, 1998
IRB Approval Number: 98-1-38
Number of Human Subjects who participated in this project/protocol during
01/16/97 - 01/16/98: 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 the use of surplus blood collected for another project. No additional risks to subjects are incurred as a result of this grant.
CONFIDENTIALITY
Confidentiality provisions are the same as those of the source protocol. Only samples collected under consent processes that inform subjects that their samples may be used in other research projects may be used by fellows under this training grant.
Project Identifier: LBNL-79-106-H02
Project Title:
Lipoproteins and Atherogenesis in Transgenic Animals
Principal Investigator:
Dr. Ronald M. Krauss
Project started in: 1979
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 4
Protocol/Subproject # 1
Protocol/Subproject Identifier: CRC Coll #3
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 14, 1997
IRB Approval Number: 97-2-107
Number of Human Subjects who participated in this project/protocol during
02/14/97 - 01/06/98: 0
Last period of approval before protocol was discontinued.
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 analyses 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 mathematical ability to examine HDL subclasses did not exist. Data from the same population of 427 were analyzed over a period of several years; no new subjects or additional risks were involved.
This protocol was discontinued in January, 1998. No work was done under this protocol in FY 98.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 13, 1998
IRB Approval Number: 98-2-64
Number of Human Subjects who participated in this project/protocol during
02/13/97 - 02/13/98: 9
Type of Human Subjects Involvement:
TITLE: Blood Donations for Family Studies
OBJECTIVES
The objective of this study is to examine the inheritance of lipid and lipoprotein levels and the physical properties, as well as chemical composition, of human plasma proteins in order to obtain insights on how to control heart diseases.
METHODOLOGY
Up to 80cc of blood are drawn from subjects via venipuncture. Additionally, a medical interview is conducted with each subject in which demographic information, family/personal health history, dietary, exercise and smoking habits, etc., are requested.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
The risks are those common to venipuncture (bruising, slight risk of infection). Please note that the figure given for Number of Human Subjects, is the number of samples collected; some subjects may have given multiple samples.
CONFIDENTIALITY
Collection of samples is not anonymous. Subjects are informed that a portion of the blood will be stored for possible future analysis by collaborating investigators. Lipoprotein analysis results are supplied to the subject's personal physician only when requested by the subject.
IRB Review:
Type of Review: Full Board
Most Recent Approval: March 13, 1998
IRB Approval Number: 98-2-69
Number of Human Subjects who participated in this project/protocol during
03/13/97 - 03/13/98: 0
Type of Human Subjects Involvement:
TITLE: Blood Donations for Transgenic Studies
OBJECTIVES
The objective of this study is to produce mice which carry specific human transgenes. This will enable researchers to study the phenotypic effects of specific genes in an animal model.
METHODOLOGY
Subjects will be recruited from the "Blood Donations for Family Studies" protocol (CRC Protocol #1). Up to 80cc of blood is drawn via venipuncture. Additionally, a medical interview is conducted with each subject in which demographic information, family/personal health history, dietary, exercise and smoking habits, etc., are requested. DNA will be obtained for the white blood cells and used as a source of transgenes.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
The risks are those common to venipuncture (bruising, slight risk of infection). Subjects are also informed that there is no plan for them to share in any income arising from the new transgenic mouse strains.
CONFIDENTIALITY
Collection of samples is not anonymous, but samples are supplied to the transgenic facility anonymously. The identity of the human gene donors will not be linked to the resultant mouse strains.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 13, 1998
IRB Approval Number: 98-2-64
Number of Human Subjects who participated in this project/protocol during
02/13/97 - 02/13/98: 293
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 the frequency of donor use. Some donors may be asked to fast overnight prior to blood withdrawal.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Risks are those common to venipuncture (bruising, mild risk of infection). Please note that the figure given for Number of Human Subjects, is the number of samples collected; some subjects may have given multiple samples.
CONFIDENTIALITY
Collection of samples is not anonymous. Subjects are informed that a portion of the blood will be stored for possible future analysis by collaborating investigators. Lipoprotein analysis results are supplied to the subject's personal physician only when requested by the subject.
Project Identifier: LBNL-79-108-H01
Project Title:
Characterization of Human Mammary Cells
Principal Investigator:
Dr. Martha R. Stampfer
Project started in: 1979
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Field Task Proposal title: "Rapid Transformation Assay" Account #4417
Assignment #CA24844
Total Funding: $534,000
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: Expedited
Most Recent Approval: March 09, 1998
IRB Approval Number: 98-3-103
Number of Human Subjects who participated in this project/protocol during
03/09/97 - 03/09/98: 0
Type 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.
IRB Review:
Type of Review: Expedited
Most Recent Approval: March 12, 1998
IRB Approval Number: 98-3-103
Number of Human Subjects who participated in this project/protocol during
03/12/97 - 03/12/98: 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.
These samples are not collected anonymously, but arrive at the Laboratory already identified by code number.
Project Identifier: LBNL-80-001-H01
Project Title:
Myocardial Flow, Function, and Metabolism by PET & MRI (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 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Project continues to be funded by the National Heart, Lung and Blood Institute (NHLBI). No funding is reported because no funds were spent on human subjects in FY 1998.
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 3
Protocol/Subproject # 1
Protocol/Subproject Identifier: RMP 1
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 15, 1997
IRB Approval Number: 97-8-144
Number of Human Subjects who participated in this project/protocol during
08/15/97 - 07/24/98: 0
Last period of approval before being discontinued.
Type of Human Subjects Involvement:
TITLE: Coronary Artery Disease Evaluation by Quantitative Perfusion Studies Using Rubidium 82 and PET
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).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET scan(s) are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
THIS PROTOCOL WAS DISCONTINUED IN JULY, 1998.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 28, 1998
IRB Approval Number: 98-8-125
Number of Human Subjects who participated in this project/protocol during
08/28/97 - 08/28/98: 0
Type of Human Subjects Involvement:
TITLE: Coronary Artery Disease Evaluation by Quantitative Perfusion Studies Using 13NH3 and PET
OBJECTIVES
The purpose of this project is to develop noninvasive, rapid, and economical methods for the evaluation of cardiac ischemia. This protocol will evaluate the clinical utility of quantitative heart perfusion data obtained with the radiotracer 13-nitrogen ammonia (13NH3) and Positron Emission Tomography (PET). The PET scan may provide information that could benefit the patient in his/her overall therapy management, but such a benefit is not assured. Society would benefit from improved and more economical diagnostic tests.
METHODOLOGY
A catheter will be placed in a vein in one arm to inject the radiotracers and to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. A blood glucose test will be performed, and patients with blood sugars less that 120 mg% will receive oral glucose loading. After positioning the subject in the PET scanner, a transmission scan without radiotracer will be done to allow corrections of the emission data. Next the first 35 mCi dose of 13NH3 is injected and a resting PET scan is taken. Between 30 and 40 minutes after the initial tracer injection, dipyridamole will be infused intravenously. The second 13NH3 injection is given about 4 minutes after the perfusion is completed and the final PET scan begins shortly thereafter. Subjects may not move during the scans. The total procedure should take about 120 minutes.
RADIATION/CHEMICAL SUBSTANCES
13-nitrogen ammonia; dipyridamole
INVOLVEMENT OF HUMAN SUBJECTS
Risks include: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray); and the routine risks associated with any clinical use of dipyridamole (occasional severe chest pain, severe hypotension, respiratory distress, and vomiting or nausea; rarely, symptoms of myocardial ischemia requiring the use of aminophylline to reverse the effect; very rarely, heart attack or death).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET scans are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
NOTE: The number of subjects participating under this protocol is reported under "Experimental Medicine Clinical" (LBNL 75-001-H02). Additional subjects were not studied under this project, therefore, the number of subjects reported here is zero to prevent counting the same subjects twice.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 28, 1998
IRB Approval Number: 98-8-121
Number of Human Subjects who participated in this project/protocol during
08/28/97 - 08/28/98: 0
Type of Human Subjects Involvement:
TITLE: Coronary Artery Disease Evaluation by 13-Ammonia Perfusion and Deoxyglucose Uptake Measured by PET and Three-Dimensional MR Myocardial Tagging
OBJECTIVES
The purpose of this project is to develop noninvasive, rapid, and economical methods for the evaluation of myocardial perfusion and metabolism. This protocol will compare magnetic resonance imaging (MRI) strain data from rest and low dose dobutamine stress conditions to PET 13-ammonia/ 18F-fluorodeoxyglucose (FDG) studies to determine which is the superior technique. The PET scan may provide information that could benefit the patient in his/her overall therapy management, but such a benefit is not assured. Society would benefit from improved and more economical diagnostic tests.
METHODOLOGY
MRI: The standard medical procedure for myocardial tagging image will be used. Subjects will discontinue beta-blocker medications 48 hours before the procedure (with the permission of their personal physician/cardiologist). A venous catheter will be placed and heart rate and blood pressure monitors attached. After a resting MRI, dobutamine will be administered as a cardiac stressor. Drugs to counteract the effect of the dobutamine, if needed, will be on hand.
PET: Patients will fast the night before scanning. Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm to inject the radiotracers and to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. First the 13-ammonia scan is performed. Subjects are then allowed to void if necessary. Then a transmission scan without radiotracer is performed to allow corrections of the emission data. Lastly, the 18-FDG study is done. Subjects may not move during the scans. The total procedure should take about 120 minutes.
RADIATION/CHEMICAL SUBSTANCES
MRI: dobutamine
PET: Fluorine-18 fluorodeoxyglucose; nitrogen-13 ammonia
INVOLVEMENT OF HUMAN SUBJECTS
Each of the subjects will have two MRI studies but most subjects will have only a single 13-ammonia vs 18-FDG uptake PET study.
MRI risks include: venous catheter (bruising, faintness); the discomfort of lying still in an enclosed space for a long period of time; the rare chance of an allergic reaction to dobutamine; the possibility of discomfort associated with discontinuing medication 48 hours prior to the study; and the rare possibility (as with any stress test) of arrythmia, heart attack, or death.
PET scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and or MRI are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
NOTE: The number of subjects participating under this protocol is reported under "Experimental Medicine Clinical" (LBNL 75-001-H02). Additional subjects were not studied under this project, therefore, the number of subjects reported here is zero to prevent counting the same subjects twice.
Project Identifier: LBNL-82-001-H04
Project Title:
Quantitative Cardiovascular Research
Principal Investigator:
Dr. Thomas F. Budinger
Project started in: 1982
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
This training grant supports post-doctoral students who may participate in human research, but does not support research directly.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: September 09, 1998
IRB Approval Number: 98-8-126
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 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 Protocols (RMPs) 49, 50 and 24 (see LBNL 80-001-H01 and LBNL-84-001-H03, respectively). No additional risks to human subjects are incurred as a result of this project.
CONFIDENTIALITY
Confidentiality provisions are reported under the individual protocols.
Project Identifier: LBNL-84-001-H03
Project Title:
Alzheimer's Disease as a Systemic Disorder (Formerly: Cardiovascular Relationships in Alzheimer's Disease)
Principal Investigator:
Dr. Thomas F. Budinger
Project started in: 1984
Project Funding Information:
Project did not receive funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Explanation:
Funding for this project ended in June, 1997.
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 3
Protocol/Subproject # 1
Protocol/Subproject Identifier: RMP 24
IRB Review:
Type of Review: Full Board
Most Recent Approval: June 05, 1998
IRB Approval Number: 98-6-105
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 5
Type of Human Subjects Involvement:
OBJECTIVES
The objectives of this study are to utilize magnetic resonance imaging (MRI) and positron emission tomography (PET) on patients with Alzheimer's disease, Parkinson's disease, and multi-infarct dementia to understand the longitudinal effects of these conditions on cerebral metabolism and to develop a new serotonin-based radiotracer which will provide a measure of the presynaptic degeneration in these cases; correlate the presynaptic degeneration with behavioral changes. The new tracer will also be used to investigate serotonergic degeneration in these diseases. Societal benefits may include a greater understanding of dementing illnesses.
METHODOLOGY
Subjects are accompanied by an adult family member or guardian to assure an appropriate consent process. Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm and another will be placed in an artery or vein of the hand on the other arm. The venous catheter will be used to inject the radiotracer and the arterial (or other venous) catheter will be used to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. After a half-hour uptake phase, subjects are asked to empty their bladder to keep the radiation exposure to the bladder as low as possible. Subjects then watch a video display terminal on which words are presented. A delayed word presentation is used to determine the duration of subjects' memory. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last 60 to 90 minutes. Subsequently, the subjects may be placed in an MRI scanner for 2 scans totaling approximately 30 minutes.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Fluorine-18 Fluorodeoxyglucose
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); arterial catheter (bruising, pain, faintness); radiation (equivalent to back x-ray). If an arterial catheter is to be placed, lidocaine is used to provide local anesthesia before placing the catheter.
MRI scan risk includes: discomfort associated with lying still in an enclosed space.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and/or MRI are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena. In patients whose cognition is or may be impaired, the consent of the responsible next of kin or conservator as well as the assent of the patient will be sought.
SPECIAL NOTE
This study was formerly included in this database as a subprotocol of "Longitudinal SPECT and PET Studies of Dementia" (LBNL-88-073-H02). LBNL-88-073-H02 has now been discontinued.
IRB Review:
Type of Review: Full Board
Most Recent Approval: June 06, 1997
IRB Approval Number: 97-6-100
Number of Human Subjects who participated in this project/protocol during
06/06/97 - 04/23/98: 0
Last period of approval before being discontinued.
Type of Human Subjects Involvement:
TITLE: Alcohol and Memory
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.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET scan(s) are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena. In patients whose cognition is or may be impaired, the consent of the responsible next of kin or conservator as well as the assent of the patient will be sought.
THIS PROTOCOL WAS DISCONTINUED IN APRIL, 1998
IRB Review:
Type of Review: Expedited
Most Recent Approval: February 25, 1998
IRB Approval Number: 97-12-54
Number of Human Subjects who participated in this project/protocol during
02/25/98 - 09/30/98: 0
Initial period of approval falling within FY98.
Type of Human Subjects Involvement:
TITLE: Cardiovascular Relationships in Alzheimer's Disease --Determination of Peripheral Vascular Reactivity
OBJECTIVES
The goal of this study is to demonstrate the presence or absence of strong correlations between Alzheimer's disease (AD) and peripheral cardiovascular disease. Societal benefits may include a greater understanding of dementing illnesses.
METHODOLOGY
An equal number of control subjects and AD patients will be recruited. Patient subjects are accompanied by an adult family member or guardian to assure an appropriate consent process. AD patients will have been previously evaluated by their treating clinic, and these results will be made available to the researchers.
On the day of the study, a small sample of venous blood will be drawn for lipoprotein analysis in order to correlate LDL levels, reactivity and subject illness. Vascular reactivity to the tightening and releasing of a blood pressure cuff will then be non-invasively measured using a Food and Drug Administration approved Doppler flow system.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
None
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include: venous catheter (bruising, faintness), discomfort due to the squeezing of the blood pressure cuff.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. The results from the venous blood analysis are supplied to the patients' personal physicians upon request. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena. In patients whose cognition is or may be impaired, the consent of the responsible next of kin or conservator as well as the assent of the patient will be sought.
Project Identifier: LBNL-88-073-H02
Project Title:
Longitudinal SPECT & PET Studies of Dementia
Principal Investigator:
Dr. William J. Jagust
Principal Investigator's Institution:
Project started in: 1988
This project ended in Fiscal Year 1998.
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 3
Protocol/Subproject # 1
Protocol/Subproject Identifier: RMP 24
IRB Review:
Type of Review: Full Board
Most Recent Approval: June 05, 1998
IRB Approval Number: 98-6-105
Number of Human Subjects who participated in this project/protocol during
06/05/97 - 06/05/98: 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 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 radiotra