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-XB
Number of Human Subjects Projects reported: 71
Project Identifier: BNL-74-113
Project Title:
Labeling of Blood Elements with Radioactive Nuclides
Principal Investigator:
Dr. Prantika Som
Project started in: 1974
This project ended in Fiscal Year 1998.
Project Funding Information:
Project did not receive funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 04, 1998
Number of Human Subjects who participated in this project/protocol during
08/04/97 - 08/04/98: 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. All records are confidential and may not be disclosed without the subject's written consent, except that the FDA and/or other funding institutions may inspect the records.
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 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: March 03, 1998
Number of Human Subjects who participated in this project/protocol during
03/03/97 - 03/03/98: 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. All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
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 did not receive funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 07, 1998
Number of Human Subjects who participated in this project/protocol during
04/07/97 - 04/07/98: 0
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); 4) 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 (360 mrem) 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.
All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
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
This project ended in Fiscal Year 1998.
Project Funding Information:
Project did not receive funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 01, 1998
Number of Human Subjects who participated in this project/protocol during
09/01/97 - 09/01/98: 0
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 11C-cocaine which is given at a dose that is about 1,000 times lower than that which would produce a behavioral effect. 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 (600 mrem) 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.
All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
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 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: November 05, 1997
Number of Human Subjects who participated in this project/protocol during
11/05/96 - 11/05/97: 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 the 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 (1066 mrem) 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.
All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
Project Identifier: BNL-89-220
Project Title:
Whole Body Distribution of 11-C-Labeled Cogentin in Humans
Principal Investigator:
Dr. Joanna S. Fowler
Project started in: 1989
This project ended in Fiscal Year 1998.
Project Funding Information:
Project did not receive funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 03, 1998
Number of Human Subjects who participated in this project/protocol during
02/03/97 - 02/03/98: 0
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
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 (1500 mrem) 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.
All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
Project Identifier: BNL-89-222
Project Title:
New and Old Models in Body Composition: Ethnic Specificity
Principal Investigator:
Dr. Avraham Dilmanian
Project started in: 1989
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 05, 1998
Number of Human Subjects who participated in this project/protocol during
05/05/97 - 05/05/98: 21
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. All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
Project Identifier: BNL-89-225
Project Title:
Nutritional and Intestinal Consequences of Immunodeficiency States
Principal Investigator:
Dr. Avraham Dilmanian
Project started in: 1989
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 05, 1998
Number of Human Subjects who participated in this project/protocol during
05/05/97 - 05/05/98: 27
Type of Human Subjects Involvement:
Previous studies documented the frequent occurrence of severe, progressive malnutrition in Acquired Immune Deficiency Syndrome (AIDS). The long term goals of this study are 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 AIDS, 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. All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
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 did not receive funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
FDA review of preliminary dose escalation results were not completed during this period.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 03, 1998
Number of Human Subjects who participated in this project/protocol during
02/03/97 - 02/03/98: 0
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. All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
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 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 03, 1998
Number of Human Subjects who participated in this project/protocol during
02/03/97 - 02/03/98: 3,200
Type of Human Subjects Involvement:
The Department of Energy (DOE) has developed a Health Surveillance System (HSS) to monitor significant causes of morbidity and death among active DOE contractor employees. The HSS focuses on enhancing the DOE's ability to monitor the health of its workers and provide an early warning of threats to worker's health. The Brookhaven National Laboratory (BNL) Occupational Medicine Clinic (OMC) participates in this project by providing information regarding all BNL employees, who work half time or greater, to the DOE. This information is collected as part of the routine operations of the Clinic. The identifying information linking this information to an individual is encoded by the OMC prior to transmission. The key for decoding the identifier is maintained exclusively by the BNL-OMC. The employee population is approximately 3,200. All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
Project Identifier: BNL-91-C24
Project Title:
Photoreactivation in Human Skin
Principal Investigator:
Dr. Betsy Sutherland
Project started in: 1991
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: March 03, 1998
Number of Human Subjects who participated in this project/protocol during
03/03/97 - 03/03/98: 10
Type of Human Subjects Involvement:
We are investigating DNA repair enzymes and their role in repair in humans. In collaboration with S.E. Whitmore, M.D., Department of Dermatology, Johns Hopkins University Hospitals, human volunteers are subjected to ultraviolet (non-ionizing) radiation from a tanning lamp and visible radiation supplied by 40 W florescence bulbs. The tanning lamp emits both UVA (320-400 nm) and UVB (290-320 nm) radiation. Exposures are from 1/2 to 3 minimal erythermal dose (MED). A MED is that quantity of radiation exposure to skin which (read at 24 hours after exposure) just elicits a pink color with defined borders of the exposed regions. After UV and/or visible exposure (and including unirradiated or sham-irradiated controls), 3 to 6 mm-diameter epidermal biopsies are obtained using lidocaine, a local anesthetic. The biopsies and sent to BNL for analysis. A small amount of bleeding can occur and is stopped immediately by treatment with a routinely-used topical chemical. The volunteer is instructed to apply an ointment and bandaid to these spots daily after bathing for one week.
Risks include sunburn or allergic reactions from the suntan lamps. Although uncommon, persons may get allergic reactions from suntan lamp treatment (red, itchy, bumpy rashes). Risks from having skin biopsies performed include bruising on the arm, scarring or dark coloration of the biopsy site. Very unusually, skin biopsy sites may become infected, or persons can have allergic reactions to the lidocaine or topical ointment.
Some people regard sun lamp treatment as beneficial and health-promoting, and perceive participation in the research as an opportunity to receive free suntanning salon sessions. These individuals tend to believe they feel better with a tan, and perceive salon sessions as a form of relaxation.
The results of the molecular analysis of DNA damages and repair will give information on the variation of repair capacity in normal humans to a DNA damaging agent, in this case UV light. The combined molecular and clinical (from the complementary studies carried out at John Hopkins on the same volunteers) will allow us to compare the molecular results to clinical data, and determine correlations between clinical responses and molecular measurements. This should provide a foundation for the identification of unusually sensitive individuals to environmental agents that can damage DNA.
Approximately 20 studies per year are performed, with a maximum of four subjects studied at one time; about 5 of these are repeat studies. All solicitation of volunteers, experimental treatments, and obtaining of biopsies is carried out under approval of the John Hopkins Joint Committee on Clinical Investigations and with informed consent of the volunteers at John Hopkins. 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. All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
Project Identifier: BNL-92-243
Project Title:
Dopamine D2 Receptor Availability Measured with Carbon-11-Labeled Raclopride
Principal Investigator:
Dr. Joanna S. Fowler
Project started in: 1992
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Total Funding: $352,000
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 03, 1998
Number of Human Subjects who participated in this project/protocol during
02/03/97 - 02/03/98: 16
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 the 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 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 (1560 mrem) 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.
All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
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 did not receive funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: June 02, 1998
Number of Human Subjects who participated in this project/protocol during
06/02/97 - 06/02/98: 0
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 and 15 Parkinson's disease patients 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 (1560 mrem) 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.
All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
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 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Total Funding: $598,000
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 13, 1998
Number of Human Subjects who participated in this project/protocol during
01/13/97 - 01/13/98: 23
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.
The radioactive substances in this project include F-18-Fluorodeoxyglucose (F-18-FDG) and C-11-Raclopride. The chemical substances in this project 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 (2530 mrem) 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 or in patients with psychiatric 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.
All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
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 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 13, 1998
Number of Human Subjects who participated in this project/protocol during
01/13/97 - 01/13/98: 2
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 (880 mrem) 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. All records are confidential and may not be disclosed without the subject's written consent and except that the FDA and/or funding agencies may inspect the records.
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 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
DA 09481
Total Funding: $40,000
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 13, 1998
Number of Human Subjects who participated in this project/protocol during
01/13/97 - 01/13/98: 2
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 (1932 mrem) 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. All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
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 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
5RO1AG13616
Total Funding: $160,000
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 13, 1998
Number of Human Subjects who participated in this project/protocol during
01/13/97 - 01/13/98: 32
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. Subjects 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 (CMRglu) 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 (2530 mrem) 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.
All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
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 did not receive funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 13, 1998
Number of Human Subjects who participated in this project/protocol during
01/13/97 - 01/13/98: 0
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 (1100 mrem) 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.
All records are confidential and may not be disclosed without the subject's written consent and except that the FDA and/or funding agencies may inspect the records.
Project Identifier: BNL-94-254
Project Title:
Evaluation of Tumors with PET and SPECT
Principal Investigator:
Dr. Gene-Jack Wang
Project started in: 1994
This project ended in Fiscal Year 1998.
Project Funding Information:
Project did not receive funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 05, 1998
Number of Human Subjects who participated in this project/protocol during
05/05/97 - 05/05/98: 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 to 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 (1740 mrem) 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. All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
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 did not receive funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 03, 1997
Number of Human Subjects who participated in this project/protocol during
12/03/96 - 12/03/97: 0
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). 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 (1320 mrem) 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. All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
Project Identifier: BNL-94-257
Project Title:
Improvement of Fission Track Analysis (FTA) of Urine Samples from the Nuclear Test Personnel Program at USDSWA
Principal Investigator:
Dr. Edward Kaplan
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 05, 1998
Number of Human Subjects who participated in this project/protocol during
05/05/97 - 05/05/98: 39
Type of Human Subjects Involvement:
Twenty-four hour urine collections from approximately 100 individuals are being 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. 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.
All records are confidential and may not be disclosed except by the subject's written permission and the FDA and/or funding agencies may inspect the records.
Project Identifier: BNL-94-258
Project Title:
Studies of Brain Aging
Principal Investigator:
Dr. Joanna S. Fowler
Project started in: 1994
Project Funding Information:
Project did not receive funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 04, 1998
Number of Human Subjects who participated in this project/protocol during
08/04/97 - 08/04/98: 0
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 function and MAO B (neuron loss is accompanied by the proliferation of glial cells which are rich in monoamine oxidase B or MAO B). The tracers are d-threo-[11C]- methylphenidate, [11C]-Raclopride, [18F]-fluoro deoxyglucose and [11C]L-Deprenyl-D2. We will study 120 normal subjects, including approximately 10 males and 10 females per decade of age. Subjects will be recruited from newspaper ads and by word of mouth. Each subject will be studied with 4 tracers. In parallel, a complete neurological evaluation is performed in all subjects to determine the cognitive and motor consequences of age-related degeneration of the dopamine system. The studies will be carried out within 6 weeks. However, when possible, the four tracer studies will be completed in two days to minimize the number of catheterizations. 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 a large population exposed at doses as low as those delivered in this procedure (1840 mrem) has been reported. The estimation of risk of harm can only be obtained 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 a 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.
All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
Project Identifier: BNL-94-C25
Project Title:
Studies of Human Anatomical Specimens with the Multiple Energy Computed Tomography (MECT) System at the NSLS
Principal Investigator:
Dr. Avraham Dilmanian
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Phantom studies were performed.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 01, 1998
Number of Human Subjects who participated in this project/protocol during
09/01/97 - 09/01/98: 0
Type of Human Subjects Involvement:
This project relates to the use of normal and diseased human anatomical specimens from cadavers, and biopsy specimens from subjects undergoing endarterectomy of the carotid artery at another institution that are subsequently imaged with the Multiple Energy Computed Tomography (MECT) System at the BNL National Synchrotron Light Source (NSLS). The studies will provide information about the viability of MECT to be used for certain imaging applications. In particular, the investigators will study MECT's capability to image separately the three main tissue components of the plaque, i.e., calcified tissue, fat/cholesterol, and fibrous tissue. They expect to use two anatomical specimens in a single beam time, which is available on the average of eight times a year.
There are no risks to human subjects in this project.
All records are confidential and may not be disclosed except that the FDA and/or funding agencies may inspect the records.
Project Identifier: BNL-95-249B
Project Title:
Imaging the Dopamine Presynaptic Neuron with 11-C Methylphenidate (4 injections)
Principal Investigator:
Dr. Joanna S. Fowler
Project started in: 1995
This project ended in Fiscal Year 1998.
Project Funding Information:
Project did not receive funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 11, 1998
Number of Human Subjects who participated in this project/protocol during
05/11/97 - 05/11/98: 0
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
Cocaine and methylphenidate (MP) are both psychostimulant drugs. Yet cocaine is considered one of the most reinforcing and addictive drugs of abuse, while MP is widely used to treat attention deficit disorder in children. MP has a similar affinity for the dopamine transporter (DAT) as cocaine. We propose to use positron emission tomography (PET) in conjunction with 11-C methylphenidate to measure brain pharmacokinetics of MP, d-threo methylphenidate, to measure DAT occupancy after single and repeated intravenous (iv) MP administration, and 11-C cocaine to evaluate binding inhibition by pharmacological doses of MP. We propose to study 25 subjects each year for three years. Each subject will receive four PET scans over a period of 3-4 weeks. 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 (1560 mrem) 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, methylphendiate should not be given to patients with cardiac disease or patients with a past history of seizure or psychiatric 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 injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.
All records are confidential and may not be disclosed without the subject's written consent and except that the FDA and/or funding agencies may inspect the records.
Project Identifier: BNL-95-255B
Project Title:
11-C-L-Deprenyl-D2 and 18-FDG for Study of Neurodegenerative Diseases
Principal Investigator:
Dr. Joanna S. Fowler
Project started in: 1995
Project Funding Information:
Project did not receive funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 03, 1997
Number of Human Subjects who participated in this project/protocol during
12/03/96 - 12/03/97: 0
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
This study will examine the use of 11-C-L-Deprenyl-D2 as a tracer for the understanding of the basic cellular biochemistry, physiology and pharmacology of neurodegenerative diseases like Parkinson's and Alzheimer's or brain injury such as brain tumors, epilepsy or head trauma. We will compare this with 18-Fluorodeoxyglucose (18-FDG) which generally provides an index of decreased neuronal activity (brain function). This is a basic study of cellular changes accompanying the neurodegenerative process. Subjects will include 12 normal subjects and 23 subjects with either Alzheimer's, epilepsy, brain tumor, Parkinson's or head trauma, all of whom will be studied with 5 millicuries (mCi) of 18-FDG and 15 mCi or less of 11-C-L-Deprenyl-D2 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 (2530 mrem) 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. All records are confidential and may not be disclosed without the subject's written consent and except that the FDA and/or funding agencies may inspect the records.
Project Identifier: BNL-95-255C
Project Title:
[11C]Clorgyline for MAO A Mapping and [11C]L-Deprenyl-D2 for MAO B Mapping
Principal Investigator:
Dr. Joanna S. Fowler
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 03, 1997
Number of Human Subjects who participated in this project/protocol during
12/03/96 - 12/03/97: 1
Type of Human Subjects Involvement:
The purpose of this study is to determine the effects of cigarette smoke on the human brain. The study will include cigarette smokers as a comparison group. This study will focus specifically on how cigarette smoke affects monoamine oxidase, an enzyme which participates in the regulation of communication between nerve cells. This information will provide knowledge which may be of value in developing treatments for smoking cessation and in understanding some of the relationships between smoking and neurological and psychiatric disorders. Subjects will be studied with either [11C]L-Deprenyl-D2 (a tracer for the MAO B subtype of the enzyme) or [11C]Clorgyline (a tracer for the MAO A subtype of the enzyme), or both. A total of 30 subjects will be studied. After administration of the radioactive tracer, 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 (1320 mrem) 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. All records are confidential and may not be disclosed without the subject's written consent and except that the FDA and/or funding agencies may inspect the records.
Project Identifier: BNL-95-260
Project Title:
Boron Neutron Capture Therapy of Glioblastoma Multiforme at the Brookhaven Medical Research Reactor (BMRR)
Principal Investigator:
Dr. Jeffrey A. Coderre
Project started in: 1995
This project ended in Fiscal Year 1998.
Project Funding Information:
Project did not receive funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 13, 1998
Number of Human Subjects who participated in this project/protocol during
01/13/97 - 01/13/98: 0
Type of Human Subjects Involvement:
We propose to determine a safe starting dose for Boron Neutron Capture Therapy (BNCT), evaluate any adverse effects of BNCT and evaluate the effectiveness of BNCT in patients with glioblastoma multiforme. Irradiation will be carried out at the epithermal beam of the Brookhaven Medical Research Reactor (BMRR) following an intravenous infusion of p-boronophenylalanine-fructose (BPA-F). We propose to study 14 patients at three to four weeks following BPA-F biodistribution at first craniotomy for tumor debulking and 14 patients at three to four weeks following BPA biodistribution at second craniotomy for tumor debulking. No repeat studies are proposed in this protocol.
During the BNCT procedures at the epithermal neutron beam of the BMRR, the patients will be exposed to high LET radiations (alpha-particles, Li-7 nuclei) resulting from the capture of slow "thermal" neutrons by 10-B nuclei and to protons and gamma photons. Patients receive up to 370 milligrams per kilogram (mg/kg) of the amino acid analog boronophenylalanine (10-BPA) intravenously in conjunction with debulking craniotomy and/or in conjunction with the BNCT procedure. For the biodistribution phase of the study, the 10-BPA-F is infused intravenously for 1 to 2 hours prior to the surgical debulking of the tumor. Samples of the tumor, including normal brain tissue if any, are analyzed for 10-B content. For the BNCT phase, 10-BPA-F is injected intravenously for 1-2 hours. Approximately 1 hour following the completion of the infusion, the patient's head is exposed to the epithermal neutron beam. Complications may include nausea, vomiting, brain swelling, headaches, muscular weakness, loss of coordination, somnolence, seizures, stupor, memory loss, hearing loss, impaired speech, alopecia, ulceration and necrosis of scalp, cataracts, blindness, skull bone necrosis, loss of bodily functions due to brain damage, coma or death. The recruitment of new subjects to this protocol was terminated in March, 1996. All records are confidential and may not be disclosed except by the subject's written permission and the FDA and/or funding agencies may inspect the records.
Project Identifier: BNL-95-260A
Project Title:
Boron Neutron Capture Therapy (BNCT) of Glioblastoma Multiforme at the BMRR (Prior Radiation)
Principal Investigator:
Dr. Jeffrey A. Coderre
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
The estimated budget for patient studies is $1.6 million, which is divided between protocols 260A, 266, 286, 287, 288.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 13, 1998
Number of Human Subjects who participated in this project/protocol during
01/13/97 - 01/13/98: 1
Type of Human Subjects Involvement:
The objective of this study is to evaluate the safety of a marginally higher and conceivably more hazardous dose of radiation in the normal brain than is tested under the companion protocol (BNL-95-260). A total of five patients with glioblastoma multiforme will be studied using BNCT following a two hour intravenous infusion of p-boronophenylalanine-fructose (10-BPA-F) at a dose of up to 370 milligrams (mg) 10-BPA per kilogram (kg). The peak dose to normal brain shall be ~12.6 gray equivalent (Gy-Eq) delivered at a dose rate of approximately 27 centigray equivalent per minute (cGy-Eq/min). The deepest contrast enhanced tumor margin shall be between 6 centimeters (cm) and 6.8 cm from the scalp surface and the patient will have received no more than 500 cGy of brain irradiation. The biodistribution phase may be dispensed with for those patients who have had more than one craniotomy or whose contrast enhanced computed tomography (CT) and/or magnetic resonance imaging (MRI) scans show no residual tumor at the time of referral for BNCT. Repeat BNCT shall not be performed under this protocol. During the BNCT procedure at the epithermal neutron beam of the Brookhaven Medical Research Reactor (BMRR), the patients are exposed to high LET radiations (alpha-particles and Li-7 nuclei) resulting from the capture of slow "thermal" neutrons by 10-B nuclei and to protons and gamma photons. The patients receive up to 370 mg/kg of 10-BPA-F intravenously in conjunction with debulking craniotomy and/or in conjunction with the BNCT procedure. For the biodistribution phase of the study, 10-BPA-F is infused intravenously for 1-2 hours prior to the surgical debulking of the tumor. Samples of the tumor, including normal brain tissue, if any, and blood are analyzed for 10-B content. For the BNCT phase of the study, 10-BPA-F is injected intravenously over 1-2 hours. Approximately 1 hour following the completion of the infusion, the patient's head is exposed to the epithermal neutron beam. Complications may include nausea, vomiting, brain swelling, headaches, muscular weakness, loss of coordination, somnolence, seizures, stupor, memory loss, hearing loss, impaired speech, alopecia, ulceration and necrosis of scalp, cataracts, blindness, skull bone necrosis, loss of bodily functions due to brain damage, coma, or death. Recruitment of new subjects to this protocol was terminated in March, 1996. All records are confidential and may not be disclosed except by the subject's written permission and the FDA and/or funding agencies may inspect the records.
Project Identifier: BNL-96-203B
Project Title:
The Use of Parnate to Assess if 11C-Clorgyline Binds to MAO A in Human Brain and Liver
Principal Investigator:
Dr. Joanna S. Fowler
Project started in: 1996
This project ended in Fiscal Year 1998.
Project Funding Information:
Project did not receive funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: March 03, 1998
Number of Human Subjects who participated in this project/protocol during
03/03/97 - 03/03/98: 0
Type of Human Subjects Involvement:
Internal administration of radioactive substances to human subjects.
The purpose of this study is to measure the inhibition of 11C-Clorgyline by the pre-administration of Parnate given orally for three days at a dose of 10 mg per day. This is done to determine the specificity of 11C-Clorgyline for MAO A. Each subject has a baseline measure and one measure after Parnate. Approximately 10 subjects per year will be studied. 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 (400 mrem) 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. Subjects taking parnate may experience hypertensive reactions if they also ingest foods high in tyramine (red wine, aged cheese, pickled fish, etc.). Subjects have been instructed to refrain from eating these foods while taking parnate and for several days after taking parnate. All records are confidential and may not be disclosed without the subject's written permission and except that the FDA and/or funding agencies may inspect the records.
Project Identifier: BNL-96-216B
Project Title:
Occupation of Dopamine Transporters by Pharmacological Doses of Cocaine
Principal Investigator:
Dr. Joanna S. Fowler
Project started in: 1996
This project ended in Fiscal Year 1998.
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.