Ms. Mona Rowe
Brookhaven National Laboratory
Bldg. 134
Upton, NY 11973-5000
Phone: 516-344-2345
Fax: 516-344-3368
Email: mrowe@bnl.gov
Projects are approved by an IRB located at: Brookhaven 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- 1313
Number of Human Subjects Projects reported: 58
Project Identifier: BNL-74-113
Project Title:
Labeling of Blood Elements with Radioactive Nuclides
Principal Investigator:
Dr. Prantika Som
Project started in: 1974
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
No human subjects were studied during the reporting period.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 04, 1996
Number of Human Subjects who participated in this project/protocol during
09/04/95 - 09/04/96: 0
Type of Human Subjects Involvement:
This project involves drawing of approximately 25-50 milliliters (ml) of blood from normal volunteers and labeling different blood components with radioactive nuclides in vitro in order to develop new compounds for nuclear medicine applications. Up to 20 normal volunteers will donate blood for this study each year. Each subject may volunteer 2-3 times. There is a slight possibility of infection and localized bleeding into the tissues.
Project Identifier: BNL-75-134
Project Title:
Mechanisms of Chromosomal Aberration Production
Principal Investigator:
Dr. Michael A. Bender
Project started in: 1975
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: October 02, 1996
Number of Human Subjects who participated in this project/protocol during
10/02/95 - 10/02/96: 3
Type of Human Subjects Involvement:
Normal, healthy volunteers are asked to provide up to 100 milliliters (ml) of sterile venous blood samples by venipuncture. These samples are used in in vitro experiments on chromosomal aberration production. No exposure of volunteers to drugs, radionuclides or devices is involved. There is a slight possibility of infection and localized bleeding into the tissues.
Project Identifier: BNL-77-146
Project Title:
DNA Repair - Human and E. Coli Photoreactivating Enzymes
Principal Investigator:
Dr. Betsy M. Sutherland
Project started in: 1977
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: March 08, 1996
Number of Human Subjects who participated in this project/protocol during
03/08/95 - 03/08/96: 2
Type of Human Subjects Involvement:
We are studying DNA damage and repair in human tissues. Our recent studies indicate that repair in human tissues is much more rapid than in human cells in culture, and make these studies critical to understanding the ability of people to cope with DNA damaging agents in the environment. We use white blood cells from healthy human volunteers in these experiments; the volunteers donate small quantities by approved medical procedure. After withdrawal of blood from the volunteers, the blood cells are separated and used as a source of photoreactivating enzyme, which repairs cyclobutyl pyrimidine dimers in DNA, as well as a source of non-cultured human cells for studies of DNA damage and repair. DNA damages are inflicted by ultraviolet lamps, a Cesium source or by HZE (high atomic number, high energy) particles.
Project Identifier: BNL-86-203
Project Title:
Localization of Functional Brain Monoamine Oxidase with 11-C-Clorgyline, 11-C-Deprenyl and PET
Principal Investigator:
Dr. Joanna S. Fowler
Project started in: 1986
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Total Funding: $177,000
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 03, 1996
Number of Human Subjects who participated in this project/protocol during
04/03/95 - 04/03/96: 25
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
We anticipate studying functional monoamine oxidase (MAO) activity with the short-lived positron emitter tracers, 11-C-Deprenyl or Clorgyline for a number of purposes including: 1) establishing a normal database using normal subjects of different ages; 2) assessing the stability of repeated measures of MAO activity in normal subjects; 3) assessing MAO activity in brain tumors (glioma); 3) assessing the effect of different doses of drugs, particularly MAO inhibitors on MAO activity; 5) assessing the duration of action of MAO inhibitor drugs; and 6) assessing the effect of cigarette smoking on MAO activity in brain. Each subject will have from one to four studies over a one year period. We anticipate studying approximately 20 subjects per year. Most of these subjects will receive 2-3 injections of 11-C-Deprenyl or Clorgyline. We will also study patients with neurological, neurodegenerative and psychiatric diseases, including Parkinson's, epilepsy, substance abuse, cancer and Alzheimer's disease. After tracer administration, the subjects are subsequently scanned with positron emission tomography (PET). A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Arterial catheterization has the following rare but possible complications: pain during placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance is injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.
Project Identifier: BNL-86-210
Project Title:
K-Edge Angiography with Synchrotron X-Rays
Principal Investigator:
Dr. William Thomlinson
Project started in: 1986
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: June 05, 1996
Number of Human Subjects who participated in this project/protocol during
06/05/95 - 06/05/96: 3
Type of Human Subjects Involvement:
This project is developing the application of synchrotron radiation sources to the imaging of human coronary arteries. The principal purpose is to image the arteries with a technique which has minimal risk for the patient. This study uses a venous injection of iodinated contrast agent. To date, the program has focused on the human related technical parameters of the procedure, such as contrast injection rates and volumes, timing of image sequences, and patient position. Simultaneously, upgrades of the imaging and x-ray optical systems have occurred. A potential effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this study has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Risks from the procedure may include severe allergic reaction to the iodine-containing dye, mechanical tear of a vein, local bleeding, impaired kidney function, and reaction to local leakage of the dye. Other complications may include blood clots, irregularities of heart beat, heart attack and death. The likelihood of serious complications is believed to be less than 0.5 percent.
Project Identifier: BNL-86-C1
Project Title:
Renal Sequelae of Excessive Lead Store
Principal Investigator:
Dr. Keith Jones
Project started in: 1986
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
BNL is not funded for this project. Our collaborator is funded by NIH.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 03, 1996
Number of Human Subjects who participated in this project/protocol during
04/03/95 - 04/03/96: 59
Type of Human Subjects Involvement:
The purpose of this study is to determine tibial bone lead in subjects suspected of excessive past lead absorption. Tibial lead determined by x-ray fluorescence (XRF) will be compared to other estimates of lead exposure, e.g., past history, blood lead, and ethylene diamine tetra acetate (EDTA) lead mobilization test. The BNL contribution to the studies will be participation in the bone lead concentration measurements using K-shell x-ray fluorescence. These measurements will be part of the larger studies involving renal sequelae and other health effects of excessive lead stores. The studies are being carried out at the University of Medicine and Dentistry of New Jersey. No subjects are seen at BNL. BNL's participation is the original design and testing of the equipment for obtaining values for bone lead concentrations. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses.
Project Identifier: BNL-88-216
Project Title:
A Study of Carbon-11 Cocaine Binding in Human Brain and Heart
Principal Investigator:
Dr. Joanna S. Fowler
Project started in: 1988
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 04, 1996
Number of Human Subjects who participated in this project/protocol during
09/04/95 - 09/04/96: 1
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
This project involves the use of 11-C-cocaine to assess the following: 1) pharmacokinetics of cocaine in human brain and heart in normal controls and cocaine abusers; and 2) the use of 11-C-cocaine as a ligand to monitor the dopamine transporter in the presynaptic dopamine neuron. This tracer is used to assess neuronal mass to determine the extent of presynaptic dopamine degeneration. There are no pharmacological effects from the cocaine. This project studies normal controls, cocaine abusers, and patients with Parkinson's disease or schizophrenia. Most subjects will have repeat studies after a three month interval. Approximately 15 subjects per year will be studied. After C-11-cocaine administration, the subjects are subsequently scanned with positron emission tomography (PET). A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Arterial catheterization has the following rare but possible complications: pain during placement of the catheter; a risk of bleeding at the skin puncture site; the possibility of local infection and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.
Project Identifier: BNL-88-217
Project Title:
The Use of Oxygen-15-Labeled Water to Assess Cerebral Blood Flow
Principal Investigator:
Dr. Joanna S. Fowler
Project started in: 1988
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
DOE/OHER funded this project, but no subjects were studied during the reporting year.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: October 02, 1996
Number of Human Subjects who participated in this project/protocol during
10/02/95 - 10/02/96: 0
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
Oxygen-15-labeled water will be used to measure regional blood flow in brain and heart. The purpose is to: 1) measure changes in regional cerebral blood flow in psychiatric diseases; 2) assess regional brain activation secondary to external stimulation; and 3) assess cardiac flow and its effect by pharmacologic intervention (methylphenidate). Patients studied include normal controls, cocaine abusers, and patients with myocardial infarction. Approximately 15 subjects per year will be studied, with a total of 2 to 3 scans each. After O-15-water intravenous administration, the subjects are subsequently scanned with positron emission tomography (PET). A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Methylphenidate is a mild central nervous system stimulant used to treat attention deficit disorder and narcolepsy. It increases heart rate and blood pressure and can cause a behavioral "high". It can also elicit negative feelings of anxiety. In the event that either cardiovascular or behavioral complications occur, they can be effectively treated with an intramuscular injection of a neuroleptic. Since methylphenidate will be administered intravenously, the likelihood of cardiac stimulation is higher. There is also some evidence that methylphenidate may lower the seizure threshold in some individuals who have a prior history of seizure disorders, and, very rarely, in individuals with no history of seizure disorders. Therefore, methylphenidate will not be given to patients with cardiac disease or patients with seizure disorders. Arterial catheterization has the following rare but possible complications: pain during placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance is injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.
Project Identifier: BNL-89-220
Project Title:
Whole Body Distribution of 11-C-Labeled Cogentin in Humans
Principal Investigator:
Dr. Steven L. Dewey
Project started in: 1989
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 07, 1996
Number of Human Subjects who participated in this project/protocol during
02/07/95 - 02/07/96: 0
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
This project proposes to use positron emission tomography (PET) to investigate the capacity to alter neurochemical function in response to acute neuroleptic-induced receptor blockade in chronic schizophrenia. F-18-Fluorodeoxyglucose (18-FDG) will be used in a repeated measure designed to examine regional changes in glucose metabolism following administration of a single pharmacological challenge dose of the neuroleptic drug haloperidol. This dose is sufficient to induce receptor blockage. Over a period of three years, approximately 24 subjects will be studied twice with 18-FDG. In the second part of these studies, PET and the muscarinic cholinergic ligand 11-C-benztropine (cogentin), intravenously administered, will be used to measure regional changes in muscarinic activity following intravenous administration of the haloperidol challenge on the separate, but functionally related muscarinic cholinergic system. These measures may provide a neurochemical basis for interpreting treatment response, for clinical sub-typing and for developing new treatment strategies. The subjects have a short-lived positron emitter tracer administered and are subsequently scanned with PET. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Several uncomfortable reactions may occur following the administration of haloperidol: sedation, listlessness, decreased motivation, decreased blood pressure, painful muscular contractions, allergic drug reactions, dry mouth or blurred vision. Muscular reactions can and will be relieved with benzotropine. Arterial catheterization has the following rare, but possible complications: pain during placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.
Project Identifier: BNL-89-222
Project Title:
New and Old Models in Body Composition: Ethnic Specificity
Principal Investigator:
Dr. Ruimei Ma
Project started in: 1989
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Funding was not received for human subjects research during FY 96.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: July 13, 1996
Number of Human Subjects who participated in this project/protocol during
07/13/95 - 07/13/96: 0
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
Obesity and its associated medical complications represent a major health problem in black women. Evaluating the prevalence and underlying pathogenesis of obesity in black women requires accurate estimates of body fat and the metabolically active tissue mass. The aims of this project are to 1) expand our subject pool to provide definitive coefficients for two-compartment models in women as a function of age, ethnicity and body fat; 2) model resting metabolic rate in relation to extensive body composition measurements in this diverse group of subjects; and 3) critically evaluate body composition methodology and models in tracking compartmental changes in obese women losing weight on a hypocaloric diet over three months. Elemental body compositions will be determined by whole body counting, in vivo neutron activation analysis and tritiated water dilution method. Human subjects will be exposed to ionizing radiation including neutrons, gamma-rays and electrons. Subjects will be given tritiated water by mouth. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as that delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses.
Project Identifier: BNL-89-223
Project Title:
Black and White Races, Body Composition and Osteoporosis
Principal Investigator:
Dr. Ruimei Ma
Project started in: 1989
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Funding was not received for human subjects research during FY 96.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: July 13, 1996
Number of Human Subjects who participated in this project/protocol during
07/13/95 - 07/13/96: 0
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
The long term objective of this study is to develop strategies for the prevention of osteoporosis in black women. Since osteoporosis has been a greater public health problem in white women, most studies have excluded racial minorities to limit extraneous variation. However, the number of black women over 65 years of age is increasing rapidly. Since hip fracture incidence rates increase exponentially after menopause, an increase in longevity of 5-6 years is expected to cause a doubling of incidence rates. Three hundred black and white women between the ages of 20 and 80 years will be studied. Each of these subjects will undergo total body calcium determination. Sixty subjects will have baseline measurements of total body nitrogen and total body water. These subjects will return on an annual basis for five years, but will only have total body calcium determination on each subsequent visit. Elemental body composition, including total body calcium, will be determined by whole body counting, in vivo neutron activation analysis and tritiated water dilution method. Subjects will be exposed to ionizing radiation including neutrons, gamma-rays and electrons. Subjects will be given tritiated water by mouth. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses.
Project Identifier: BNL-89-224
Project Title:
The Effects of Strength Training and Weight Reduction on Bone and Muscle Mass in Postmenopausal Women
Principal Investigator:
Dr. Ruimei Ma
Project started in: 1989
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Funding was not received for human subjects research for FY 96.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: July 13, 1996
Number of Human Subjects who participated in this project/protocol during
07/13/95 - 07/13/96: 0
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
This study examines the effects of a hypocaloric diet and strength training exercise on changes in bone and muscle mass in postmenopausal Caucasian women. Two groups of women will be studied: 1) women less than 110% of ideal body weight (IBW). The women in this group will be randomly assigned to either a sedentary control group or a strength training group for 12 months. 2) overweight women (130-140% of IBW) who will lose weight over the 12-month period. The women in this group will be randomly assigned to either a weight loss by diet alone group or a weight loss by diet and strength training group. We will use state-of-the-art techniques to quantify total body calcium, nitrogen, potassium, carbon, regional bone density, body fat, muscle mass, regional muscle mass, calcium absorption, nutritional status, endocrine status and fitness level. This study will be the first to examine longitudinal changes in body composition, muscle strength and bone density by increasing muscle mass through strength training and decreasing it through weight loss. A total of 100 subjects will be studied. Each of these subjects will undergo in vivo neutron activation (IVNA) analysis at the beginning and the end of the one year program. Elemental body compositions will be determined by whole body counting, in vivo neutron activation analysis and tritiated water dilution method. Subjects will be exposed to ionizing radiation including neutrons, gamma-rays and electrons. Subjects will be given tritiated water by mouth. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only be extrapolation from much higher doses.
Project Identifier: BNL-89-225
Project Title:
Nutritional and Intestinal Consequences of Immunodeficiency States
Principal Investigator:
Dr. Ruimei Ma
Project started in: 1989
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Funding was not received for human subjects research during FY 96.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: July 13, 1996
Number of Human Subjects who participated in this project/protocol during
07/13/95 - 07/13/96: 0
Type of Human Subjects Involvement:
Previous studies documented the frequent occurrence of severe, progressive malnutrition in Acquired Immune Deficiency Syndrome (AIDS). The long term goal of this study is to provide an understanding of the pathogenesis of malnutrition in AIDS, a scientific rationale for nutritional therapy, and realistic expectations for the results of such therapy. The specific aims of this proposal are to define the metabolic mechanisms underlying the alterations in body composition that occur as a result of the acquired immune deficiency syndrome, their association with active human immunodeficiency virus (HIV) infection, and their relationship to altered release of cytokines. The centerpiece of these studies will be precise measurements of body composition which will allow precise determination of depletion or repletion. Elemental body compositions will be determined by whole body counting and in vivo neutron activation analysis. Subjects will be exposed three times per year to ionizing radiation including neutrons, gamma-rays and electrons. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses.
Project Identifier: BNL-89-C13
Project Title:
Biodistribution of p-Boronophenylalanine in Patients with Malignant Melanoma and Malignant Brain Tumors
Principal Investigator:
Dr. Jeffrey A. Coderre
Project started in: 1989
This project ended in Fiscal Year 1996.
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 05, 1995
Number of Human Subjects who participated in this project/protocol during
04/05/94 - 04/05/95: 6
Type of Human Subjects Involvement:
The boron-containing amino acid p-boronophenylalanine (BPA) is used as the boron-delivery agent for an experimental radiotherapy known as boron neutron capture therapy (BNCT). BPA-based BNCT has been shown to be effective in treating several types of tumors carried in laboratory animals. The key to effective BNCT is the selective delivery of boron to the tumor. The Phase I biodistribution study of BPA in human cancer patients has two objectives: 1) to establish the safety and degree of toxicity of BPA administered intravenously (i.v.); and 2) to measure the amount of boron accumulated in human tumors. Patients with melanoma, glioblastoma or breast cancer, already scheduled for surgery, are given BPA. Serial blood and urine samples are collected as well as tumor (and normal tissue, if available) samples at the time of the surgery. The number of subjects per year will be approximately 10-20. There will be no repeat studies.
Aside from hypersensitivity, there are no known risks to the patients from BPA.
Project Identifier: BNL-90-229
Project Title:
Sn-117m (4+) DTPA in the Treatment of Osseous Metastases
Principal Investigator:
Dr. Suresh C. Srivastava
Project started in: 1990
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Total Funding: $285,000
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 07, 1996
Number of Human Subjects who participated in this project/protocol during
02/07/95 - 02/07/96: 13
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
A majority of the subjects treated with Sn-117m (4+) diethylenetriaminepentaacetic acid (DTPA) at levels of 0.143, 0.179, 0.229 and 0.286 millicurie per kilogram (mCi/kg) of body weight have shown partial to complete pain relief. The plan is to increase the administered activity in steps of 25% and to observe the individuals for at least three months before going to the next level. We plan to escalate the dose up to a level at which level two marrow-toxicity is encountered (white blood cell count 2000-2900; platelets 50-75 x 1,000). This level is considered acceptable for chemotherapeutic regimens. We will, of course, continue to follow all patients for as long as possible and would consider retreatment after three months of observation. The risks to the subjects are only a slight possibility of infection and localized bleeding into the tissues from the injection. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses.
Project Identifier: BNL-91-C14
Project Title:
UAW-Ford/BNL-IPAG Information System Research Demonstration Project: Phase I
Principal Investigator:
Dr. Jerome Barancik
Project started in: 1991
This project ended in Fiscal Year 1996.
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: April 05, 1995
Number of Human Subjects who participated in this project/protocol during
04/05/94 - 04/05/95: 0
Type of Human Subjects Involvement:
The overall objective of this project is to introduce and demonstrate the efficacy of a safety and injury control information system designed to measure process and injury patterns systematically before and after introduction of injury countermeasures. Using BNL developed epidemiologic research and surveillance methodology, existing human data from two selected Ford plants will be acquired and analyzed. BNL expects to identify 4,000 to 6,000 subjects for both plants combined from the existing computerized databases. The data will be representative of a period not exceeding 12 months. The data will be aggregated into grouped numerical format for scientific presentations and reports. All records are maintained in strict confidence and are stored in accordance with Clinical Record storage at BNL. Data items include age, sex, job/process codes and descriptions, length of employment on job, nature, type and severity of injury, outcomes including workdays lost, and time and place of event. There are no risks to subjects.
Project Identifier: BNL-91-C15
Project Title:
Health Surveillance System
Principal Investigator:
Dr. Bryce D. Breitenstein
Project started in: 1991
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 07, 1996
Number of Human Subjects who participated in this project/protocol during
02/07/95 - 02/07/96: 3,200
Type of Human Subjects Involvement:
The Department of Energy (DOE) is developing a Health Surveillance System (HSS) to monitor significant causes of morbidity and death among active DOE contractor employees. Development of the HSS focuses on enhancing the DOE's ability to monitor the health of its workers and provide an early warning of threats to workers' health. This project includes the use of routinely collected Occupational Medicine Clinic data from all half time or greater Brookhaven National Laboratory employees. The employee population is approximately 3,200.
Project Identifier: BNL-91-C24
Project Title:
Photoreactivation in Human Skin
Principal Investigator:
Dr. Betsy Sutherland
Project started in: 1991
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
No human subjects were studied during FY 96.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: March 08, 1996
Number of Human Subjects who participated in this project/protocol during
03/08/95 - 03/08/96: 0
Type of Human Subjects Involvement:
We are investigating DNA repair enzymes and their role in repair in humans. In collaboration with Johns Hopkins School of Medicine, healthy human volunteers are exposed to ultraviolet or visible light, and biopsies obtained immediately after or after time for repair. The biopsies are returned to BNL for analysis. We carry out approximately 20 studies per year, with a maximum of four subjects studied at one time; about 5 of these are repeat studies. We also study human neonatal foreskins (10-15/year) obtained from Suffolk Central or Brookhaven Hospital. The tissue, which would otherwise be discarded, serves as an excellent source of human tissue for studies of DNA damage and for initiation of cell cultures for in vitro studies. Anonymity of mother and child is maintained to preserve confidentiality; because of the nature of the tissue, no subject is sampled more than once.
Project Identifier: BNL-92-243
Project Title:
Dopamine D2 Receptor Availability Measured with Carbon-11-Labeled Raclopride
Principal Investigator:
Dr. Steven L. Dewey
Project started in: 1992
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 07, 1996
Number of Human Subjects who participated in this project/protocol during
02/07/95 - 02/07/96: 24
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
These studies are designed to assess the availability of the dopamine D2 receptor in the human brain as it relates to the concentration of endogenous dopamine. The radiotracer, 11-C-raclopride, has been shown to be sensitive to changes in endogenous dopamine and we will use this reaction to probe the effects of changes in endogenous dopamine that are induced by different drugs using high resolution positron emission tomography (PET). The studies may provide insight into the mechanisms of actions of these drugs and may also help us understand the interactions that exist between the dopaminergic system and other systems that are anatomically linked to it. Approximately 15 normal volunteers, 15 alcoholic patients, 15 psychiatric patients, and 15 cocaine abusers will be studied using 11-C-raclopride and methylphenidate. The subjects will be males between the ages of 18-85. The subjects will have the short-lived positron emitter tracer (C-11-raclopride) administered intravenously and then be scanned with PET.
A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only from extrapolation from much higher doses. Methylphenidate is a mild central nervous system stimulant used to treat attention deficit disorder and narcolepsy. It increases heart rate and blood pressure and can cause a behavioral high. It can also elicit negative feelings of anxiety. In the event that either cardiovascular or behavioral complications occur, they can be effectively treated with an intramuscular injection of a neuroleptic. Since methylphenidate will be administered intravenously, the likelihood of cardiac stimulation is higher. There is also some evidence that methylphenidate may lower the seizure threshold in some individuals with no history of seizure disorders. Therefore, methylphenidate should not be given to patients with cardiac disease or patients with a past history of seizure disorders. Arterial catheterization has the following rare, but possible complications: pain during placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance is injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.
Project Identifier: BNL-92-245
Project Title:
Adult Fluoride Study
Principal Investigator:
Dr. Gary Leske
Principal Investigator's Institution: State University of New York at Stony Brook
Project started in: 1992
This project ended in Fiscal Year 1996.
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: March 01, 1996
Number of Human Subjects who participated in this project/protocol during
03/01/95 - 03/01/96: 401
Type of Human Subjects Involvement:
The purpose of this study is to determine the effectiveness of the daily use of a commercially available fluoride mouthrinse or fluoride gel in reducing dental decay in adults. A visual/tactile dental exam with no x-rays will be given initially. Subsequent examinations will be given at 16, 32 and 48 months. Approximately 500-1000 adults will be studied. The subjects will be age 45 or older with at least 15 natural teeth, at least 2 teeth with receding gums and no significant loosening of the teeth. Each subject will be studied 3 times over a 4 year period. This project ended April, 1996.
Project Identifier: BNL-92-246
Project Title:
Body Composition of Diabetic Patients with Hyperkalemia
Principal Investigator:
Dr. Ruimei Ma
Project started in: 1992
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Funding was not received for human subjects research during FY 96.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 10, 1996
Number of Human Subjects who participated in this project/protocol during
01/10/95 - 01/10/96: 0
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
The general objective of this study is to understand better the pathogenesis, significance and effects of treatment of hyperkalemia in patients with advance Type II diabetes mellitus (IIDM). Specifically, it will attempt to relate hyperkalemia and treatment (diuresis) directed toward its normalization to changes in body composition, e.g., total body potassium by whole body counting of natural K-40; total body nitrogen by prompt gamma neutron activation, total body sodium, total body calcium and total body chloride by delayed gamma neutron activation; and total body water by isotope dilution of tritiated water. A total of 40 subjects will be studied over a period of two years. Approximately half of these will be patients with IIDM and half will be control subjects. Half of the subjects will be studied twice (once before and once after diuretic therapy). Elemental body compositions will be determined by whole body counting, in vivo neutron activation analysis and tritiated water dilution method. Subjects will be exposed to ionizing radiation including neutrons, gamma-rays and electrons. Subjects will be given tritiated water by mouth. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses.
Project Identifier: BNL-92-C19
Project Title:
Clinical Evaluation of Two New Chelates for Labeling an Anti-CEA Antibody with In-111 for Immunoscintigraphy
Principal Investigator:
Dr. Suresh C. Srivastava
Project started in: 1992
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Prelminary work involving development of the isotope was performed during FY 96.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 07, 1995
Number of Human Subjects who participated in this project/protocol during
12/07/94 - 12/07/95: 0
Type of Human Subjects Involvement:
The object of this study is to evaluate the efficacy of In-111 labeled anti-CEA F(ab)'2 conjugates of two new chelating agents for immunoscintigraphy in patients with colorectal adenocarcinoma. The two chelates developed at BNL complex indium more strongly and their use is expected to reduce nonspecific uptake of radioactivity in patients, particularly to the liver. The BNL synthesized ligands are conjugated to the antibody and the conjugates sent to the University of Nantes, France, for subsequent radiolabeling and patient studies at that institution. Approximately 10 subjects with colon cancer, primary or recurrent, were studied in the initial phase of this project. There was also imaging and an attempt to obtain biopsy samples of certain tissues. All subjects were studied in France.
As far as we know, there are no risks. The potential benefits may allow detection of disease not available by other means.
Project Identifier: BNL-93-249
Project Title:
Imaging the Dopamine Presynaptic Neuron with 11-C Methylphenidate
Principal Investigator:
Dr. Joanna S. Fowler
Project started in: 1993
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 07, 1996
Number of Human Subjects who participated in this project/protocol during
08/07/95 - 08/07/96: 3
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
Methylphenidate (Ritalin) is a mild central nervous system stimulant used primarily in the treatment of attention-deficit hyperactivity disorder (ADHD) and narcolepsy. These studies are designed to measure the pharmacokinetics and regional localization of methylphenidate in the brain and in the body using C-11 labeled methylphenidate and positron emission tomography (PET). They are also designed to assess the association between methylphenidate kinetics in the brain and the behavioral effects of a pharmacologically active dose of methylphenidate (0.5 milligram/kilogram intravenously). Another part of this study will compare methylphenidate binding in different types of patients to assess its sensitivity to degeneration of dopaminergic neurons and to altered presynaptic function. These studies are expected to provide insight into the behavior of methylphenidate and also to examine the feasibility of using C-11 methylphenidate as a sensitive indicator for the loss of dopaminergic nerve terminals. Approximately 15 normal volunteers (ages 18-55), 15 normal subjects (ages 55-90), 15 cocaine abusers, 15 Parkinson's disease patients and 15 patients with Alzheimer's disease will be studied. Subjects will be males and females. We will exclude all patients that are medically unstable, patients for whom discontinuation of drugs poses a risk and patients with peripheral vascular disease. Subjects will receive a maximum of 24 millicuries (mCi) of C-11 methylphenidate per quarter in 1-3 injections. The subjects have a short-lived positron emitter tracer administered and are subsequently scanned with positron emission tomography (PET).
A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Methylphenidate is a mild central nervous system stimulant used to treat attention deficit disorder and narcolepsy. It increases heart rate and blood pressure and can cause a behavioral high. It can also elicit negative feelings of anxiety. In the event that either cardiovascular or behavioral complications occur, they can be effectively treated with an intramuscular injection of a neuroleptic. Since methylphenidate will be administered intravenously, the likelihood of cardiac stimulation is higher. There is also some evidence that methylphenidate may lower the seizure threshold in some individuals with no history of seizure disorders. Therefore, methylphenidate should not be given to patients with cardiac disease or patients with a past history of seizure disorders. Arterial catheterization has the following rare but possible complications: pain during placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance is injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.
Project Identifier: BNL-93-250
Project Title:
A Comparison of Different Techniques of Body Composition Analysis to Neutron Activation Analysis in Patients on Dialysis
Principal Investigator:
Dr. Ruimei Ma
Project started in: 1993
This project ended in Fiscal Year 1996.
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: November 02, 1994
Number of Human Subjects who participated in this project/protocol during
11/02/93 - 11/02/94: 20
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
Patients receiving dialysis frequently experience protein and caloric malnutrition. These nutritional concerns have led to new approaches to dialysis therapy. The nutritionist faced with evaluation of the dialysis patient has a compelling need to assess body composition. Until recently only anthropometric evaluation was readily available but the accuracy and reliability of this technique in dialysis patients is questionable. Additional techniques, such as Dual Photon Absorptiometry (DPA), Bioelectric Impedance (BIA) and Infrared Interactance (IR) are now clinically available but have not been validated against the gold standard (in vivo neutron activation analysis) in dialysis patients. The purpose of this pilot study is to compare the results obtained with those clinically available techniques with the results obtained by in vitro neutron activation analysis. A total of 20 subjects will be studied, only once. Elemental body compositions will be determined by whole body counting, in vivo neutron activation analysis and tritiated water dilution method. Subjects will be exposed to ionizing radiation including neutrons, gamma-rays and electrons. Subjects will be given tritiated water by mouth. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses.
Project Identifier: BNL-93-252
Project Title:
Validation of a Method for Estimating Muscle Protein Mass and Muscle Protein Breakdown in Humans
Principal Investigator:
Dr. Ruimei Ma
Project started in: 1993
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Funding was not received for this project and no subjects were studied.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: October 02, 1996
Number of Human Subjects who participated in this project/protocol during
10/02/95 - 10/02/96: 0
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
This study will investigate whether the proposed diagnostic technique (isotopic dilution of 3-methyl-histidine (3MH)) can be used to directly measure the mass of muscle contained in the body of humans. These results will be correlated with body compositions determined by whole body counting (TBK), total body water measurement (TBW), and neutron activation analysis (TBN and TBC) at BNL. Since the measurement of TBK, TBW, TBC and TBN provides the most definitive techniques for studying body composition, the present study will determine whether the use of saliva samples will suffice for estimating the decay curve of 3MH, and hence can be used for the determination of muscle mass in vivo. By mathematically modeling the change in the stable isotope in the salivary fluid, the muscle mass as well as the breakdown of this muscle can be measured. A total of 20 subjects will be studied. They will be measured only once. Elemental body compositions will be determined by whole body counting, in vivo neutron activation analysis and tritiated water dilution method. Subjects will be exposed to ionizing radiation including neutrons, gamma-rays and electrons. Subjects will be given tritiated water by mouth. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses.
Project Identifier: BNL-94-144B
Project Title:
Evaluation of 18-FDG in the Diagnosis of Glucose Metabolism in the Human Body (Cocaine Abusers)
Principal Investigator:
Dr. Joanna S. Fowler
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Total Funding: $62,000
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 10, 1996
Number of Human Subjects who participated in this project/protocol during
01/10/95 - 01/10/96: 7
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
The purpose of these studies is to investigate the involvement of the dopamine (DA) system in cocaine addiction. More specifically, these studies use positron emission tomography (PET) to evaluate if decreased frontal metabolism in cocaine abusers is related to decreased function of presynaptic DA neurons (PDN). PDN function is evaluated in cocaine abusers and normal controls by monitoring DA release in response to methylphenidate (MP), a drug that increases synaptic DA by inhibiting DA transporter sites. Changes in DA concentration after MP are evaluated by measuring its effects on 11-C-Raclopride binding and on glucose metabolism. Because DA competes with 11-C-Raclopride for the DA D-2 receptors, this strategy enables us to assess relative changes in DA induced by MP. We also assess the effects of MP on frontal brain glucose metabolism (FDG) to evaluate in the same individual the relationship between changes in DA and changes in regional brain metabolism.
Radioactive substances include F-18-Fluorodeoxyglucose (F-18-FDG) and C-11-Raclopride. Chemical substances include methylphenidate. The subjects have a short-lived positron emitter tracer administered and are subsequently scanned with positron emission tomography (PET). A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses.
Methylphenidate is a mild central nervous system stimulant used to treat attention deficit disorder and narcolepsy. It increases heart rate and blood pressure and can cause a behavioral "high". It can also elicit negative feelings of anxiety. In the event that either cardiovascular or behavioral complications occur, they can be effectively treated with an intramuscular injection of a neuroleptic. Since methylphenidate will be administered intravenously, the likelihood of cardiac stimulation is higher. There is also some evidence that methylphenidate may lower the seizure threshold in some individuals who have a prior history of seizure disorders, and very rarely, in individuals with no history of seizure disorders. Therefore, methylphenidate should not be given to patients with cardiac disease or patients with a past history of seizure disorders. Arterial catheterization has the following rare but possible complications: pain during placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance is injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.
Project Identifier: BNL-94-144C
Project Title:
Evaluation of 18-FDG in the Diagnosis of Glucose Metabolism in the Human Body (Tumors)
Principal Investigator:
Dr. Joanna S. Fowler
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 10, 1996
Number of Human Subjects who participated in this project/protocol during
01/10/95 - 01/10/96: 13
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
The purpose of this protocol is to evaluate functional changes of normal brain tissue in patients undergoing radiation therapy for brain tumors. Approximately 25 patients will be studied, including follow-up patients from prior years. Each patient will be studied up to four times per year: at baseline, after radiation, and two or four months later. The subjects have a short-lived positron emitter tracer (F-18-Fluorodeoxyglucose or F-18-FDG) administered and are subsequently scanned with positron emission tomography (PET). A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.
Project Identifier: BNL-94-144D
Project Title:
Evaluation of 18-FDG in the Diagnosis of Glucose Metabolism in the Human Body (Alcoholics)
Principal Investigator:
Dr. Joanna S. Fowler
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
DA 09481
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 10, 1996
Number of Human Subjects who participated in this project/protocol during
01/10/95 - 01/10/96: 15
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
Alcoholics will be tested during early as well as late detoxification. This strategy will enable us to assess whether there is recovery after detoxification. The patients will be scanned for a baseline metabolic rate and again after drug challenge with lorazepam to test the involvement of specific brain receptors. Approximately 20 alcoholics and 20 controls will be studied. The subjects have a short-lived positron emitter tracer (F-18-Fluorodeoxyglucose or F-18-FDG) and lorazepam administered and are subsequently scanned with positron emission tomography (PET). A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Whenever blood is removed or a substance is injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. Lorazepam may produce sleepiness and drowsiness in sensitive individuals. Therefore, subjects will not be allowed to drive home after they are administered lorazepam.
Project Identifier: BNL-94-144E
Project Title:
Evaluation of 18-FDG in the Diagnosis of Glucose Metabolism in the Human Body (Alzheimer's)
Principal Investigator:
Dr. Joanna S. Fowler
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 10, 1996
Number of Human Subjects who participated in this project/protocol during
01/10/95 - 01/10/96: 20
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
The primary hypothesis of this protocol is that among non-demented elderly (ranging from normal through minimum impairment) hippocampal metabolic changes as measured by 18-FDG (fluoro-deoxyglucose) PET scans precede cognitive deterioration, the clinical diagnosis of dementia and metabolic neocortical changes. Approximately 20 subjects per year will be studied. They will have annual longitudinal follow up positron emission tomography (PET) studies and we will analyze all longitudinal studies (baseline and follow up) with respect to our hypothesis. Our preliminary analysis shows that the size of the hippocampus at the baseline, using magnetic resonance imaging (MRI), predicts the neocortical regional brain glucose metabolism change at follow up. In other words, those cases with smaller hippocampi had reduced neocortical cerebral metabolic rate of glucose (CRMglu) on their follow up PET scans, suggesting that the first site of pathology is the hippocampus.
Subjects have a short-lived positron emitter tracer administered and are subsequently scanned with PET. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Arterial catheterization has the following rare but possible complications: pain during placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance is injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.
Project Identifier: BNL-94-144F
Project Title:
Evaluation of 18-FDG in the Diagnosis of Glucose Metabolism in the Human Body (Schizophrenics)
Principal Investigator:
Dr. Joanna S. Fowler
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 10, 1996
Number of Human Subjects who participated in this project/protocol during
01/10/95 - 01/10/96: 6
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
These studies are a continuation of our examination of the effect of the haloperidol challenge in neuroleptic-responsive and resistant schizophrenic subjects. We have hypothesized that responsive subjects will show a metabolic response to the haloperidol challenge similar to that observed in normals, whereas resistant subjects will fail to show this response. These studies may help us to manage individuals suffering from this disorder by further characterizing the disorder and finding more appropriate medication for the non-responsive group.
Approximately 20 schizophrenics and 10 normals will be studied. Each subject will receive a baseline F-18-Fluorodeoxyglucose (18-FDG) scan and be given a 5 milligram (mg) haloperidol challenge 12 hours prior to the second 18-FDG scan. The subjects have a short-lived positron emitter tracer administered and are subsequently scanned with positron emission tomography (PET). A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Whenever blood is removed or a substance is injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. Several uncomfortable reactions may occur following the administration of haloperidol: sedation, listlessness, decreased motivation, decreased blood pressure, painful muscular contractions, allergic drug reactions, dry mouth or blurred vision. Muscular reactions can and will be relieved with benztropine.
Project Identifier: BNL-94-254
Project Title:
Evaluation of Tumors with PET and SPECT
Principal Investigator:
Dr. Gene-Jack Wang
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Funds were provided to perform preliminary phantom studies to assess the relative sensitivity and to plan subject dose, but the SPECT is not ready for human studies.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: June 06, 1996
Number of Human Subjects who participated in this project/protocol during
06/06/95 - 06/06/96: 0
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
We propose to image human tumors using positron emission tomography (PET) and single photon emission computed tomography (SPECT) and compare the sensitivity and specificity of these imaging modalities in showing the location of the tumors, differentiating the condition of tumors and where they disseminate. F-18-Fluorodeoxyglucose (F-18-FDG) has been very useful as a tracer to evaluate malignant tumors; however, its clinical applications have been limited by the high cost and limited availability of PET scanners. If SPECT can be used to image F-18-FDG in tumors, it will expand the clinical applications of F-18-FDG, since SPECT cameras are widely available. The following specific aims are proposed: 1) studies to compare F-18-FDG imaging with PET and SPECT on patients with breast cancer; and 2) gadolinium-enhanced magnetic resonance imaging (MRI) for anatomical location. Approximately 20 subjects will be studied with PET, SPECT and MRI. The subjects have a short-lived positron emitter administered and are subsequently scanned with PET and SPECT. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.
Project Identifier: BNL-94-255
Project Title:
11-C-L-Deprenyl-D2 for MAO B Mapping
Principal Investigator:
Dr. Joanna S. Fowler
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
NS 15380
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 10, 1996
Number of Human Subjects who participated in this project/protocol during
01/10/95 - 01/10/96: 4
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
Monoamine oxidase B (MAO B) is a brain enzyme which increases with normal aging, in neurodegenerative disease, and in brain injury. It is also a therapeutic target for drugs to treat Parkinson's disease and depression. These research studies will be aimed at understanding the association between the loss of neurons and changes in MAO B and ultimately to develop a marker which will allow us to track neuronal loss. These studies will be conducted with 11-C-L-Deprenyl-D2, a tracer which labels brain MAO B. No more than 30 subjects will be studied in a year. Subjects will receive up to 4 injections of 11-C-L-Deprenyl-D2 (a total of 30 millicuries (mCi) or less). Initial studies will be carried out on 6-10 subjects and will compare 11-C-L-Deprenyl-D2 and 11-C-L-Deprenyl. The subjects have the short-lived positron emitter tracer administered and are subsequently scanned with positron emission tomography (PET). A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Arterial catheterization has the following rare but possible complications: pain during placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance is injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.
Project Identifier: BNL-94-257
Project Title:
Improvement of Fission Track Analysis (FTA) of Urine Samples from the Nuclear Test Personnel Program at USDNA
Principal Investigator:
Dr. Edward Kaplan
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 03, 1996
Number of Human Subjects who participated in this project/protocol during
05/03/95 - 05/03/96: 22
Type of Human Subjects Involvement:
Twenty-four hour urine collections from approximately 30 individuals will be examined using a fission track procedure to quantitate excretion of plutonium-239. In time periods months and years after exposure, the urinary excretion can be related to body burden. Also measured is urinary creatinine as an indication of completeness of collection. This is a pilot study which will be extended to volunteers in other geographic areas of the country and eventually to Armed Forces veterans who participated in tests of nuclear weapons.
There are no risks to human subjects in this project.
Project Identifier: BNL-94-258
Project Title:
Studies of Brain Aging
Principal Investigator:
Dr. Nora D. Volkow
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 07, 1996
Number of Human Subjects who participated in this project/protocol during
08/07/95 - 08/07/96: 10
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
Dopamine is a neurotransmitter which is involved in movement and in cognition. The nerve cells producing dopamine are especially vulnerable and are progressively lost in the normal aging human brain. It has been postulated that some of the motor impairment and cognitive changes that occur in the elderly are associated with the loss in dopaminergic neurons. The purpose of this study is to investigate age-related changes in brain dopamine activity and neuronal loss and its consequences on brain function.
The study will use normal subjects in the age range of 20-95 who will be studied with 4 tracers. In this study we will measure 4 parameters: dopamine nerve terminals, dopamine receptors, brain func