USDOE Human Subjects Research Database, fiscal year 1995

Oak Ridge Institute for Science and Education

Project Identifier: ORAU-91-81

Project Title:

Use of Prussian Blue for Internal Decontamination of Radiocesium

Principle Investigator: Dr. Ronald E. Goans
Principle Investigator's Institution: Oak Ridge Associated Universities

Project started in: 1991

Fiscal Year 1995 Funding for Research on Human Subjects:

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

Explanation:

The program has not advanced to the point of having anyone treated with Prussian Blue and then having follow-up data collected.

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 05, 1995
IRB Approval Number: 81

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:

Internal administration of radioactive substances to human subjects.

• Other internal administration of radioactive substances:

  Therapeutic modality for treatment of Cs-137 ingestion under accident conditions.

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.

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

• Use of data collected from subjects specifically for this project.
• Use of existing data that were collected for another purpose or 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])

ORAU - 81 Prussian Blue IND Application

Prussian Blue is being proposed for use in decontaminating individuals who have been accidentally exposed internally to the radioactive element cesium (137Cs).

An investigational new drug application (IND) for Prussian Blue is nearing internal review and submission to the FDA should be completed within the next three months. Interested DTPA co-investigators will be surveyed regarding their interest in becoming a co-investigator for insoluble Prussian Blue and this drug, when approved for an IND, will be distributed to those collaborators who have a significant potential for an accident involving 137Cs. There is wide agreement in the scientific community regarding the efficacy of this compound in enhancing excretion of cesium, but the drug is currently available only in Europe under the tradename RadioGardase.

Prussian Blue at approved dose levels may cause harmless staining. No major toxic or other side effects have been observed in humans based on limited use. Available data suggest continued administration or overdosage may cause constipation. Privacy and confidentiality of data collected are assured by the DOE System of Records to the extent possible under law.