USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-95-261

Project Title:

Effects of Boron Neutron Capture Therapy on Glucose Metabolism of Glioblastoma Multiforme and Normal Brain

Principle Investigator: Dr. Gene-Jack Wang

Project started in: 1995

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: $10,000 (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 diagnostic research.
• For therapeutic research.

Internal administration of radioactive substances to human subjects.

• For diagnostic research.
• For therapeutic research.

Chemical Substances:

Internal use of chemical substances (solid, liquid, or gas) in human subjects.

• For diagnostic research.
• For therapeutic 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])

Positron emission tomography (PET) will be performed on patients who have received boron neutron capture therapy (BNCT) to measure the changes in glucose metabolism of glioblastoma multiforme (GBM) and non-tumor normal brain tissue. The study will include baseline 2-deoxy-2-[18F]-fluoro-D-glucose (F-18-FDG) PET scans obtained prior to tumor debulking and prior to BNCT. The interval between tumor debulking and BNCT will be 3-4 weeks. Post-BNCT scans will include early (~3 weeks post-BNCT), intermediate (~11 weeks post-BNCT) and, if possible, late (annually for 3 years post-BNCT) follow-up scans. These scheduled scans may be replaced by or supplemented with scans conducted to distinguish tumor recurrence from radiation necrosis. Contrast-enhanced magnetic resonance imaging (MRI) and/or CT scans will be conducted in conjunction with PET scans. Patients will serve as their own longitudinal controls. The patients included in this study will be recruited from the patients scheduled to undergo p-boronophenylalanine-fructose (BPA-F) biodistribution study in conjunction with first craniotomy. Ten patients of either sex will be studied. The subjects have a short-lived positron emitter tracer administered and are subsequently scanned with positron emission tomography (PET). A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk 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.