USDOE Human Subjects Research Database, Fiscal Year 2001

PEM Technologies, Inc.

Public Information Contact:

Dr. Irving N. Weinberg
PEM Technologies, Inc.
5611 Roosevelt Street
Bethesda, MD 20817

Phone: 301-564-0835
Fax: 301-564-5386
E-mail: INWeinberg@aol.com

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 1

PEMT-99-09511-01

"Stereotactic Needle Localization for Biopsy of Nonpalpable Breast Abnormalities"

Project Identifier: PEMT-99-09511-01

"Stereotactic Needle Localization for Biopsy of Nonpalpable Breast Abnormalities"

Principal Investigator: Dr. Irving N. Weinberg, PEM Technologies, Inc.

Project started in: 1999
This project ended in fiscal year 2001.

Project Funding Information:

Funding for Human Subjects Research:

DOE: SBIR program

$20,000.00 (Est.) for: Calendar Year 2001
Funding estimated for direct charges only (sample preparation, consultation, materials)

Information on Use of Human Subjects:

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

Identifier or number: 09511-11

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Harbor-UCLA Research & Education Institute
Most recent approval: 11/09/99
IRB approval number: 09511-01
Explanation of IRB approval:
Protocol is being resubmitted. No new clinical studies will take place until review of new protocol is complete.

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 16
Reporting period for number of human subjects: Other: 11/09/99 to 10/31/01
Explanation:

The next phase of clinical testing requires modification of the protocol, and no new clinical studies will take place under this project until review of modified protocol is complete.

Type(s) of Human Subjects Involvement:

Internal administration of radioactive substances to human subjects:

• For diagnostic research

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

• Using existing specimens or samples of bodily materials collected for another purpose.

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:

• Using existing data that were collected for other purposes or projects.

Use of human beings to develop/test instruments, materials, devices, objects, and the like or to investigate the "man-machine interface".

(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 understand intrinsic contrast of radiotracer in breast cancer, and detect changes in imaging with different camera types
Methodology: After informed consent, patients with suspected breast cancer were injected with Tc-99m SestaMIBI prior to surgery. Novel camera techniques were used to image the cancers in vivo and after removal of the tissue.
Radioactive substances or ionizing radiation: After informed consent, patients received 20-30 milliCuries of Tc-99m SestaMIBI intravenously.
Risks to human subjects: After informed consent, patients with suspected breast cancer were injected with 20-30 mCi of radiotracer Tc-99SestaMIBI intravenously prior to breast surgery. This agent is approved by the FDA for problem solving in breast disease. Images of the breast were obtained prior to surgery and of the surgical specimens after surgery. Risk was minimal as the radiotracer is already approved for this clinical indication.
Privacy/confidentiality/consent: Efforts were made to safeguard patient privacy and confidentiality. Informed consent was obtained prior to enrollment in the protocol.