USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-91-113

Project Title:

Digital Mammography

Principle Investigator: Mr. Clint M. Logan

Project started in: 1991

Fiscal Year 1995 Funding for Research on Human Subjects:

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

Explanation:

Project was approved by IRB, but not funded by anyone.

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: May 17, 1995
IRB Approval Number: 91-113

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:

Project used archival film images with personally identifiable data.

(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])

Background:

Breast cancer kills a U.S. woman every 12 minutes. Overall, 24% of breast cancer patients in the U.S. die from the disease. When detected early, only 5% die. Conventional mammography is a powerful tool, but approximately 25% of the detectable breast cancers are missed. Most of these are missed by oversight.

Objectives:

We are developing computer algorithms to reduce oversight. Secondary objectives of the research are to investigate methods of compressing or reducing digital mammograms for storage and improved methods of softcopy image display.

Methodology:

Archival film mammograms are digitized using LLNL's unique digitizing technology. These digital images are then computer processed. The main thrust of this work is to find and highlight suspicious regions. These regions are highlighted for diagnosis by a radiologist. Initially, results are evaluated by comparison to a skilled mammographer. Final performance will be measured by mammographer performance with and without computer assistance.

Ionizing Radiation:

Archival mammograms are used for this work. Human subjects are not exposed to ionizing radiation.

Involvement of Human Subjects:

A few images are accepted from those offered directly to the LLNL research team by volunteers. In these cases, volunteers give their informed consent and names and other identifying information are obscured prior to digitization.

Human subjects are exposed to no risk from this study.