Gamma Medica Ideas

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Identifier or number: 11576-01

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Gamma Medica Ideas
Most recent approval: 09/29/05
IRB approval number: 11576-01
Explanation of IRB approval:
Study was close 10/2006. Last subject enrolled was 7/2005. DOE Grant funding ended in fiscal year 2005. Additional funding was anticipated but not received. Therefore new IRB cycle was not needed.

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects: Fiscal Year 2006

Type(s) of Human Subjects Involvement:

External use of ionizing radiation on human subjects:

• For clinical research
• Other. Explain:

Mammogram series in high risk for breast cancer population.

Internal administration of radioactive substances to human subjects:

• For clinical research
• Other. Explain:

20 Mci Tc-Sestimbi IV, imaging for breast cancer in high risk for breast cancer population

(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: This is a study to develop a combined scintimammograph (SMM) and digital x-ray mammography (XMM) imaging system utilizing a dedicated breast gamma camera, a digital x-ray detector, and a specialized camera travel gantry fixture called a "bucky." This system will facilitate obtaining co-registered SMM and XMM images without moving the breast.

The system will lead to a new class of mammography machine that addresses the need for improved breast cancer screening and diagnosis in the population for which cancer is the hardest to detect, namely, radiographically dense-breast.

Hypothesis: The hypothesis in this study is that two imaging modalities will increase the sensitivity of breast cancer detection.

Methodology: Patients will be injected with 740 MBq of Tc-99m-sestamibi (Bristol-Myers Squibb Co.) into a vein on the dorsum of the foot by a nuclear medical technologist (NMT). The patient will be positioned in the mammography gantry by a technologist specially trained and meeting the requirements set by the Mammography Quality Standards Act16 for breast imaging. The NMT will acquire and process a standard two-view screening mammogram and scintimammograms of each breast using standard mammographic compression. Each breast will be imaged in two projections. The images will then be reviewed by a physician to determine if additional supplementary views are necessary.

Risks: Subjects enrolled in this study will experience some discomfort during compression, this is typical of the standard procedure for mammograms. In rare instances, compression can cause bruising. It is possible (and consistent with the hypothesis) that the metamammogram will detect an abnormality that is not evident by conventional imaging methods. This is likely to result in a recommendation for biopsy or short-term follow-up. The patient may be encouraged to undergo biopsy of a new area, if recommended. Infection or extravasation at site of injection is not likely to occur, but is possible. There will be additional radiation exposure resulting from the injection of the radionuclide approximating the same dose as a standard mammogram procedure.

Patient Privacy/Confidentiality: The informed consenting process communicates respect for patient privacy and confidentiality which are discussed in the protocol and manual. The manual, containing detailed information on the protocol, equipment, and conduct of the project, was developed for reference and especially for the benefit of project participants. This section states that all collected data will be treated confidentially and identified only by a subject identification number and subject's initials.