USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-92-C19

Project Title:

Clinical Evaluation of Two New Chelates for Labeling an Anti-CEA Antibody with 111-In for Immunoscintigraphy

Principle Investigator: Dr. Suresh C. Srivastava

Project started in: 1992

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: $30,000 (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: December 07, 1994

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

Type of Human Subjects Involvement:

Other use of human subjects:

Ligands synthesized here are conjugated to the carcinoembryonic antibody (CEA) and sent to the U. of Nantes, France, for patient studies.

(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])

The object of this study is to evaluate the efficacy of In-111 labeled anti-CEA F(ab)'2 conjugate of two new chelating agents for immunoscintigraphy in patients with colorectal adenocarcinoma. The two chelates developed at BNL complex indium more strongly and their use is expected to reduce nonspecific uptake of radioactivity in patients, particularly to the liver. The BNL synthesized ligands are conjugated to the antibody and the conjugates sent to the University of Nantes, France, for subsequent radiolabeling and patient studies at that institution. Approximately 10 subjects with colon cancer, primary or recurrent, were studied in the initial phase of this project. There was also imaging and an attempt to obtain biopsy samples of certain tissues. All subjects were studied in France.

As far as we know, there are no risks. The potential benefits may allow detection of disease not available by other means.