USDOE Human Subjects Research Database, Fiscal Year 2006

Washington University

Public Information Contact:

Dr. Michael J. Welch
Professor of Radiology Co-Director Div of Radiological Scien
Washington University School of Medicine St. Louis
510 S. Kingshighway Blvd
Saint Louis, MO 63110

Phone: 314-362-8436
Fax: 314-362-8399
E-mail: welchm@wustl.edu

Institutional Review Board (IRB):

Projects are approved by an IRB located at: Washington University
The approving IRB operates under an OHRP assurance.
OHRP assurance number: FWA00002284

Human Subject Projects:

Number of Human Subjects projects reported: 1

WASHU-06-Cu-ATSM "Preparation of Radiopharmaceuticals Labeled with Metal Radionuclides: Comparison of 60Cu-ATSM PET with 64Cu-ATSM PET in Cervical Cancer "

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Project Identifier: WASHU-06-Cu-ATSM

Project Title:

"Preparation of Radiopharmaceuticals Labeled with Metal Radionuclides: Comparison of 60Cu-ATSM PET with 64Cu-ATSM PET in Cervical Cancer"

Principal Investigator: Dr. Farrokh Dehdashti, Washington University

Project started in: 2006

Project Funding Information:

This project received funding during fiscal year 2006.

Funding for Human Subjects Research:

DOE: Office of Biological and Environmental Research (OBER)
$148,677.38 (Est.) for: Calendar Year 2006
Percent of funding associated with the use of human subjects: 1-20

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Washington University
Most recent approval: 01/25/06
IRB approval number: 05-1161

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 8
Reporting period for number of human subjects: Other: 01/25/06 to 11/13/06
Explanation:
Includes all subjects entered since initial IRB approval.

Type(s) of Human Subjects Involvement:

External use of ionizing radiation on human subjects:

For clinical research

Internal administration of radioactive substances to human subjects:

For clinical research

Internal use of chemical substances (solid, liquid, or gas) on human subjects:

For clinical research

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, etc):

Using bodily materials collected specifically for this project.

Abstract:

(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 goal is to develop a hypoxia-based imaging method for assessment of tumor hypoxia that can be readily adopted by medical centers lacking access to a cyclotron. The primary objective is to assess the quality of 60Cu-ATSM imaging as compared to 64Cu-ATSM imaging in subjects with a new diagnosis of cervcial carcinoma. Subjects are exposed to ionizing radiation from the intravenous injection of 60Cu-ATSM, 64Cu-ATSM, and from 68Ge/68Ga transmission rod sources. Subjects undergo two positron emission tomography (PET) scans on separate occasions after intravenous injection of 60Cu-ATSM and 64Cu-ATSM. Vital signs and laboratory (complete blood count, comprehensive metabolic panel blood test, and urinalysis) safety analysis occurs for each subject. Risks are limited to radiation exposure, discomfort from placement of an intravenous line, and discomfort from lying still on the imaging table. All subjects signed informed consent prior to any research studies and have the option to quit at any time. Images and associated paperwork are available only to study personnel. Participation and results are not part of the subjects medical records.

Go to list of projects at Washington University