USDOE Human Subjects Research Database, fiscal year 1995

Oak Ridge National Laboratory

Project Identifier: ORNL-93-27

Project Title:

Laser-Induced Fluorescence Detection of Cancer Without Biopsy Surgery

Principle Investigator: Dr. Tuan Vo-Dinh

Project started in: 1993

Fiscal Year 1995 Funding for Research on Human Subjects:

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

Explanation:

Funding used only for research & development of spectroscopic techniques; no money was spent on work with human subjects.

Funding Sources:

DOE: Office of Health and Environmental Research (OHER)

Amount: $300,000 (Est.)
Comments:

Above amount of funding was for basic fundamental research and development of spectroscopic techniques for chemical and biological monitoring.

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: August 03, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 30
(Reporting periods vary.)

Type of Human Subjects Involvement:

Other use of human subjects:

In vivo test performed during routine endoscopy procedure.

(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])

a. To develop a new diagnostic procedure based on laser-induced fluorescence for use in direct in vivo cancer diagnosis without requiring biopsy surgery. Normal and cancerous tissues differ in the fluorescence they produce.

b. Endogenous fluorescence of normal and malignant tissues were measured directly using a fiberoptic probe inserted in an endoscope at the Thompson Cancer Survival Center. The measurements were performed in vivo during routine endoscopy.

c. None.

d1. See item b.

d2. No additional risks added to the procedure as the fluorescence probe is passed through the biopsy channel of the endoscope.