USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-94-254

Project Title:

Evaluation of Tumors with PET and SPECT

Principle Investigator: Dr. Gene-Jack Wang

Project started in: 1994

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.

Explanation:

Funds were provided to perform preliminary phantom studies to assess the relative sensitivity and to plan subject dose.

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: May 03, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 0
(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.

Chemical Substances:

Internal use of chemical substances (solid, liquid, or gas) in 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 propose to image human tumors using positron emission tomography (PET) and single photon emission computed tomography (SPECT) and compare the sensitivity and specificity of these imaging modalities in showing the location of the tumors, differentiating the condition of tumors and where they disseminate. F-18-Fluorodeoxyglucose (F-18-FDG) has been very useful as a tracer to evaluate malignant tumors; however, its clinical applications have been limited by the high cost and limited availability of PET scanners. If SPECT can be used to image F-18-FDG in tumors, it will expand the clinical applications of F-18-FDG, since SPECT cameras are widely available. The following specific aims are proposed: 1) studies to compare F-18-FDG imaging with PET and SPECT on patients with breast cancer; and 2) gadolinium-enhanced magnetic resonance imaging (MRI) for anatomical location. Approximately 20 subjects will be studied with PET, SPECT and MRI. The subjects have a short-lived positron emitter administered and are subsequently scanned with PET and SPECT. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.