USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-94-104-H01

Project Title:

Statistical and Modeling Uncertainties in Dynamic PET

Principle Investigator: Dr. Pamela G. Coxson

Project started in: 1994

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:

Grant not funded. Pilot analysis of data was carried out while grant was pending.

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 16, 1994
IRB Approval Number: 94-8-103

Number of Human Subjects in the Last Reporting Period for this Project: 22
(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 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])

OBJECTIVES

To gain an understanding of non-measurement sources of uncertainty and their effect on kinetic parameter estimates. This study will increase the value of dynamic positron emission tomography (PET) data as a potentially objective criteria for detecting coronary disease, for assessing the location and extent of compromised tissue, and for monitoring progress of the disease over time.

METHODOLOGY

This study will examine the effect of kinetic model selection, assess variability of kinetic parameters due to measurement error in three dimensional regions of interest, investigate variability due to cardiac motion and volume of interest specification in the multi-slice data, and relate dipyridamole and adenosine blood assay levels to blood pressure, heart rate and PET kinetic parameters.

IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES

None.

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

Involvement of human subjects is limited to the analysis of dynamic PET data collected from LBNL-80-001-H01, "Cardiovascular Flow and Metabolism" (T. Budinger, principal investigator).