Project Identifier: LBNL-75-001-H02
Project Title:
Experimental Medicine Clinical (see LBL-93-6-58 in 1994 database)
Principle Investigator:
Dr. Thomas F. Budinger
Project started in: 1975
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
Funding Sources:
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 13
Protocol/Subproject # 1
Protocol/Subproject Identifier: RMP 2
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 18, 1995
IRB Approval Number: CPHS 95-8-136
Number of Human Subjects in the Last Reporting Period for this Project: 70
(Reporting periods vary.)
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 tumor treatment 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)].
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 09, 1995
IRB Approval Number: CPHS 95-6-118
Number of Human Subjects in the Last Reporting Period for this Project: 30
(Reporting periods vary.)
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. 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 12, 1995
IRB Approval Number: CHPS 95-5-61
Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)
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 in the Last Reporting Period for this Project: 3
(Reporting periods vary.)
Type of Human Subjects Involvement:
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 judgement 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).
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 18, 1995
IRB Approval Number: CPHS 95-8-138
Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)
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: October 14, 1995
IRB Approval Number: CPHS 94-10-60
Number of Human Subjects in the Last Reporting Period for this Project: 3
(Reporting periods vary.)
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 17, 1994
IRB Approval Number: CPHS 94-10-59
Number of Human Subjects in the Last Reporting Period for this Project: 7
(Reporting periods vary.)
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 12, 1995
IRB Approval Number: CPHS 95-5-58
Number of Human Subjects in the Last Reporting Period for this Project: 3
(Reporting periods vary.)
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 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 18, 1995
IRB Approval Number: CPHS 95-8-137
Number of Human Subjects in the Last Reporting Period for this Project: 7
(Reporting periods vary.)
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 13, 1994
IRB Approval Number: CPHS 94-12-58
Number of Human Subjects in the Last Reporting Period for this Project: 3
(Reporting periods vary.)
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 17, 1995
IRB Approval Number: CPHS 95-2-99
Number of Human Subjects in the Last Reporting Period for this Project: 4
(Reporting periods vary.)
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 17, 1995
IRB Approval Number: CPHS 95-5-57
Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)
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 12, 1995
IRB Approval Number: CPHS 95-5-62
Number of Human Subjects in the Last Reporting Period for this Project: 3
(Reporting periods vary.)
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).