USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-86-210

Project Title:

K-Edge Angiography with Synchrotron X-Rays

Principle Investigator: Dr. William Thomlinson

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: $50,000 (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: June 07, 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.

Chemical Substances:

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

• For diagnostic research.

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

(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])

This project is developing the application of synchrotron radiation sources to the imaging of human coronary arteries. The principal purpose is to image the arteries with a technique which has minimal risk for the patient. This study uses a venous injection of iodinated contrast agent. To date, the program has focused on the human related technical parameters of the procedure, such as contrast injection rates and volumes, timing of image sequences, and patient position. Simultaneously, upgrades of the imaging and x-ray optical systems have occurred. The program plans to image 70 patients in total, with possibly 30 patients being imaged twice. It is anticipated that some of these studies will become part of an expanded research program involving many more studies over a period of years. Those studies will focus on qualitative and quantitative characterization of arterial disease, pre- and post-treatment evaluation, and potential drug therapies. A potential 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 study has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Risks from the procedure may include severe allergic reaction to the iodine-containing dye, mechanical tear of a vein, local bleeding, impaired kidney function, and reaction to local leakage of the dye. Other complications may include blood clots, irregularities of heart beat, heart attack and death. The likelihood of serious complications is believed to be less than 0.5 percent.