USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-86-203

Project Title:

Localization of Functional Brain Monoamine Oxidase with 11-C-Clorgyline, 11-C-Deprenyl and PET

Principle Investigator: Dr. Joanna S. Fowler

Project started in: 1986

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

DOE: Office of Health and Environmental Research (OHER)

Amount: $48,000 (Est.)

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: April 05, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 2
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

• For clinical research.

Internal administration of radioactive substances to human subjects.

• For clinical research.

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

• Use of bodily materials collected from subjects specifically for this project.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

We anticipate studying functional monoamine oxidase (MAO) activity with the short-lived positron emitter tracers, 11-C-Deprenyl or Clorgyline for a number of purposes including: 1) establishing a normal database using normal subjects of different ages; 2) assessing the stability of repeated measures of MAO activity in normal subjects; 3) assessing MAO activity in brain tumors (glioma); 3) assessing the effect of different doses of drugs, particularly MAO inhibitors on MAO activity; 5) assessing the duration of action of MAO inhibitor drugs; and 6) assessing the effect of cigarette smoking on MAO activity in brain. Each subject will have from one to four studies over a one year period. We anticipate studying approximately 20 subjects per year. Most of these subjects will receive 2-3 injections of 11-C-Deprenyl or Clorgyline. We will also study patients with neurological, neurodegenerative and psychiatric diseases, including Parkinson's, epilepsy, substance abuse, cancer and Alzheimer's disease. After tracer administration, the subjects are subsequently scanned with positron emission tomography (PET). A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Arterial catheterization has the following rare but possible complications: pain during placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance is injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.