USDOE Human Subjects Research Database, fiscal year 1995

Oak Ridge Institute for Science and Education

Project Identifier: ORAU-80-61

Project Title:

The DTPA Registry Follow-Up Program

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

Project started in: 1980

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 Occupational Medicine

Amount: $0 (Est.)
Comments:

Included in EHW 1307 funding (Radiation, Medicine and Cytogenetics Program Funding)

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: 61

Number of Human Subjects in the Last Reporting Period for this Project: 610
(Reporting periods vary.)

Type of Human Subjects Involvement:

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 - 61 The DTPA Registry Follow-up program

Since its inception, the DTPA registry has documented the case histories and, in some cases, clinical data for 610 individuals who have experienced internal contamination with actinides (radioactive elements such as actinium and americium) and who subsequently received DTPA. These 610 individuals were treated with over 4500 doses of either Ca-DTPA or Zn-DTPA, either by intravenous or intramuscular injection or by nebulizer administration. The majority of patients have received only a single dose, but one patient who experienced a large exposure to a soluble isotope of americium (241Am) eventually received over 1000 doses, without adverse side effects. The DTPA registry is a unique facility which documents the historical use of chelation therapy to remove actinide contamination.