Ms. Mona
Rowe
Brookhaven National Laboratory
Bldg. 134
Upton, NY 11973-5000
Phone: 516-344-2345
Fax: 516-344-3368
E-mail: mrowe@bnl.gov
Number of Human Subjects projects reported: 78
Project Identifier:
BNL-77-146
Project Title:
"DNA Repair - Human and E. Coli Photoreactivating Enzymes"
Principal Investigator: Dr. Betsy M. Sutherland, Brookhaven National Laboratory
Project started in: 1977
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 03/02/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) 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 with the exception 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, Brookhaven National Laboratory
Project started in: 1986
This project ended in fiscal year 1999.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 04/07/98
Explanation of IRB approval:
The protocol was inactivated at its annual review 04/99.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
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 with the exception 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, Brookhaven National Laboratory
Project started in: 1988
This project ended in fiscal year 1999.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 11/05/97
Explanation of IRB approval:
This protocol was inactivated at its annual review in 11/98.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
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 with the exception 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. Lucian Wielopolski, Brookhaven National Laboratory
Project started in: 1989
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 05/04/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 36
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
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 with the exception 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. Lucian Wielopolski, Brookhaven National Laboratory
Project started in: 1989
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 05/04/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 43
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) 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 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 with the exception 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, Brookhaven National Laboratory
Project started in: 1990
This project ended in fiscal year 1999.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 02/03/98
Explanation of IRB approval:
Protocol was inactivated at its annual review 02/99.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
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 experienced 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 with the exception 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, Brookhaven National Laboratory
Project started in: 1991
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 02/02/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 3200
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) 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 with the exception 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, Brookhaven National Laboratory
Project started in: 1991
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 03/02/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 30
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
We are investigating induction of DNA damage by ultraviolet light in the absence and presence of substances applied topically to skin that may alter the transmission of skin and thus affect the level of DNA damage. In collaboration with K. Kaidbey, M.D., Ivy Laboratories, we are evaluating the effects of alpha hydroxy acid (active ingredient in anti-wrinkle creams) or of Imiquimod (causes regression of warts in non-sunlight exposed areas and is now a candidate for treatment of actinic keratoses on sunlight-exposed skin) on induction of cyclobutyl pyrimidine dimers. After UV exposure (and including unirradiated or sham-irradiated controls), 3 to 6 mm-diameter epidermal biopsies are obtained using lidocaine, a local anesthetic. The biopsies are sent to BNL for analysis. A small amount of bleeding at the biopsy site 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 or topical agents. Although uncommon, persons may get allergic reactions from 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.
Approximately 30 studies per year are performed, All solicitation of volunteers, experimental treatments, and obtaining of biopsies is carried out at Ivy Laboratories under approval of the Schulman Associates Institutional Review Board, Inc. and with informed consent of the volunteers at Ivy Labs. 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 with the exception 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, Brookhaven National Laboratory
Project started in: 1992
This project ended in fiscal year 1999.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 02/03/98
Explanation of IRB approval:
This protocol was inactivated at its annual review in 02/99.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
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 with the exception 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, Brookhaven National Laboratory
Project started in: 1993
This project ended in fiscal year 1999.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 06/02/98
Explanation of IRB approval:
This protocol was inactivated at its annual review in 06/98.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
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 with the exception 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, Brookhaven National Laboratory
Project started in: 1994
This project ended in fiscal year 1999.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 01/13/98
Explanation of IRB approval:
Protocol was inactivated at its annual review 01/99.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
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 with the exception 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, Brookhaven National Laboratory
Project started in: 1994
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 01/05/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
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 permission with the exception 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, Brookhaven National Laboratory
Project started in: 1994
This project ended in fiscal year 1999.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 01/13/98
Explanation of IRB approval:
Protocol was inactivated at its annual review 01/99.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 12
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
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 with the exception 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, Brookhaven National Laboratory
Project started in: 1994
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 01/05/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 33
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
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 with the exception 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, Brookhaven National Laboratory
Project started in: 1994
This project ended in fiscal year 1999.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 01/13/98
Explanation of IRB approval:
This protocol was inactivated at its annual review 01/99.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
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 permission with the exception 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, Brookhaven National Laboratory
Project started in: 1994
This project ended in fiscal year 1999.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 12/03/97
Explanation of IRB approval:
This protocol was inactivated at its annual review 12/98.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
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 with the exception 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, Brookhaven National Laboratory
Project started in: 1994
This project ended in fiscal year 1999.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 05/05/98
Explanation of IRB approval:
This protocol was inactivated at its annual review 05/99.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) 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 without the subject's written permission with the exception that 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, Brookhaven National Laboratory
Project started in: 1994
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 08/04/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 15
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
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 with the exception 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, Brookhaven National Laboratory
Project started in: 1994
This project ended in fiscal year 1999.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 09/01/98
Explanation of IRB approval:
This protocol was inactivated at its annual review 09/99.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) 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-95-255B
Project Title:
"11-C-L-Deprenyl-D2 and 18-FDG for Study of Neurodegenerative Diseases"
Principal Investigator: Dr. Joanna S. Fowler, Brookhaven National Laboratory
Project started in: 1995
This project ended in fiscal year 1999.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 12/03/97
Explanation of IRB approval:
This protocol was inactivated at its annual review 12/98.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
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 with the exception 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, Brookhaven National Laboratory
Project started in: 1995
This project ended in fiscal year 1999.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 12/03/97
Explanation of IRB approval:
This protocol was inactivated at its annual review 12/98.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) 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 with the exception that 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, Brookhaven National Laboratory
Project started in: 1995
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 01/13/98
Explanation of IRB approval:
No new patients were enrolled; there is one patient in long term follow up.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) 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 without the subject's written consent with the exception that the FDA and/or funding agencies may inspect the records.
Project Identifier:
BNL-96-249C
Project Title:
"Dopamine Transporter Occupancy by Oral Methylphenidate"
Principal Investigator: Dr. Joanna S. Fowler, Brookhaven National Laboratory
Project started in: 1996
This project ended in fiscal year 1999.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 06/02/98
Explanation of IRB approval:
This protocol was inactivated at its annual review 06/99.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this study is to determine the occupancy of dopamine transporter by methylphenidate (MP) doses used in the treatment of attention deficit disorder and narcolepsy. The subjects will be scanned up to four different times with [11C]d-threo-methlyphenidate: once without methylphenidate preadministration to assess baseline dopamine transporter availability, and then 120 minutes after 20 mg of MP, 120 minutes after 40 mg of MP, and 120 minutes after 60 mg of MP. Approximately 15 subjects will be studied. The subjects will be healthy volunteers, between 20-50 years old, male or female. 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 (1560 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. 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 orally, the likelihood of cardiac stimulation is lower. There is also some evidence that methylphenidate may lower the seizure threshold in some individuals who have a prior history of seizure disorders. Therefore, methylphenidate will not be given to patients with cardiac disease or patients with seizure disorders. All records are confidential and may not be disclosed without the subject's written consent with the exception that the FDA and/or funding agencies may inspect the records.
Project Identifier:
BNL-96-257B
Project Title:
"Blood and Urine Analysis for Pu-239"
Principal Investigator: Dr. Edward Kaplan, Brookhaven National Laboratory
Project started in: 1996
This project ended in fiscal year 1999.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 05/05/98
Explanation of IRB approval:
This protocol was inactivated at its annual review 05/99.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this study is to determine whether blood, rather than urine, can be used to find the level of Pu-239, which may be in the body of individuals who may have been exposed to fallout. Twenty-four hour urine collections and 50 cc blood donations from 8 individuals will be examined for fission tracks to quantitate excretion of Pu-239. There are no risks to human subjects in this project. All records are confidential and may not be disclosed without the subject's written consent with the exception that the FDA and/or funding agencies may inspect the records.
Project Identifier:
BNL-96-258B
Project Title:
"Studies of Alcohol Withdrawal"
Principal Investigator: Dr. Joanna S. Fowler, Brookhaven National Laboratory
Project started in: 1996
This project ended in fiscal year 1999.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 08/04/98
Explanation of IRB approval:
This protocol was inactivated at its annual review 08/99.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
We propose to characterize the dopamine transporter (DA) system at rest during early and late alcohol withdrawal. We will use a multiple tracer approach to assess the various DA elements: DA transporters (using [11C]-d-threo-methylphenidate), D2 receptors (using [11C]raclopride) and metabolic activity of regions connected with the DA system (using 2-deoxy-2-[18F]fluoro-D-glucose-FDG). Alcoholics will be evaluated with the three tracers twice: 2-4 weeks after last alcohol use and then 3-4 months after an alcohol free period to assess reversibility of possible DA changes. In parallel, test-retest studies will be done in non-alcoholic subjects to evaluate the reproducibility of the measures at 3-4 month intervals. Approximately 25 alcoholics and 15 control subjects will be studied. Each subject will be studied twice within a four month period. 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 (2500 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 with the exception that the FDA and/or funding agencies may inspect the records.
Project Identifier:
BNL-96-265
Project Title:
"General Magnetic Resonance Imaging (MRI) and Spectroscopic (MRS) Studies of Human Subjects"
Principal Investigator: Dr. Charles S. Springer, Brookhaven National Laboratory
Project started in: 1996
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 07/13/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 52
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The goal of this proposal is to evaluate tissue MR signal relaxivities at the 4T field strength and to conduct research aimed at increasing our understanding of the mechanisms and evolution of normal brain function and human disease states. This work will not be used for routine diagnosis. About 300 studies, all of normal adult volunteers, are ultimately expected to be made in a year. No radiopharmaceuticals (drugs) or surgical procedures will be used in this study. Each participant will be asked to complete an entry questionnaire prior to completing a consent form and being allowed into the magnet. The purpose of the entry questionnaire is to screen out individuals who may have problems in the magnet caused by metal implants, claustrophobia, etc. During the study, the subjects will be monitored using a video camera and communicated with via a two-way intercom, from the control room where the operator is located. After the study, the subjects will be asked to complete an exit form, which is to document any feeling they may have experienced during the 4T scanning. No serious ill effects have been reported to date from any of the six research facilities in the United States operating with this magnetic field strength (4T). Because of the strong magnetic field, individuals with surgically implanted metallic devices such as clips, artificial joints, certain heart valves and pacemakers will be excluded from this study, as well as subjects with claustrophobia. The possible risks due to the magnet itself are primarily related to the slight possibility of a sensation of dizziness or nausea as the subject moves in and out of the magnet or moves their head in the magnet. The magnet is thought to be able to exert a force on the fluid within the semicircular canals near the ears, thus giving a sensation of disequilibrium. The sensations go away if the head is not in motion or if the individual is not moving in and out of the magnet. Subjects are exposed to noise from the machine, for which earplugs are provided. All records are confidential and may not be disclosed without the subject's written consent with the exception that the FDA and/or funding agencies may inspect the records.
Project Identifier:
BNL-96-266
Project Title:
"BNCT of GBM at the BMRR: A Phase I/II Dose Escalation Study"
Principal Investigator: Dr. Jeffrey A. Coderre, Brookhaven National Laboratory
Project started in: 1996
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 01/05/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 6
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this study is to evaluate the safety of p-boronophenylalanine-fructose (BPA-F) in a dose escalation study, the safety of increasing average brain boron neutron capture therapy (BNCT) dose, the safety of increasing the minimum target volume BNCT dose and the safety of single field versus double field BNCT. Patients with glioblastoma multiforme will be irradiated using the epithermal neutron beam at the Brookhaven Medical Research Reactor (BMRR), following an infusion of BPA-F. During the BNCT procedure at 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. The subjects will receive up to 495 milligrams BPA per kilogram body weight as BPA-F injected intravenously for 2-3 hours. Approximately 1 hour after 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. Approximately 28 subjects will be studied. All records are confidential and may not be disclosed without the subject's written consent with the exception that the FDA and/or funding agencies may inspect the records.
Project Identifier:
BNL-96-268
Project Title:
"Brain Imaging Studies in Obesity"
Principal Investigator: Dr. Joanna S. Fowler, Brookhaven National Laboratory
Project started in: 1996
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 07/13/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 9
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this study is to investigate if there are changes in the brain dopamine system of obese individuals and to assess if these reverse to normal with weight loss. The study will use twenty normal obese subjects in the age range of 30-55 years of age. Each evaluation will entail studies with three tracers: to measure the dopamine nerve terminals - d-threo-11C-methylphenidate; to measure postsynaptic dopamine sites - 11C-raclopride; and to measure regional brain function - 18F-fluorodeoxyglucose. 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 (3440 mrem) has been observed. Thus, estimation of the 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, except that the FDA and/or funding agencies may inspect the records.
Project Identifier:
BNL-96-270
Project Title:
"Weight Loss: Bone and Muscle Skeletal Homeostasis"
Principal Investigator: Dr. Lucian Wielopolski, Brookhaven National Laboratory
Project started in: 1996
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 08/04/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 82
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement: