SBIR-STTR Award

The proposed plan is for the development of a needle biopsy and needle localization device that can be used with existing mammographic equipment. Using a stereotactic algorithm, this equipment will enable an operator to place a biopsy needle or a localization needle prior to open biopsy of the breast in three dimensions within plus or minus 1-2 millimeters. Since this method utilizes a computer and does not require photographic development, the entire process could be performed in a few minutes.In phase I, components will be selected and procured, software will be developed and an error analysis will be performed. Initial bread-board testing will be performed to verify the feasibility of this method. In phase II, a prototype device will be constructed, clinical testing will be performed, and modifications and improvements will be incorporated into th design.National Cancer Institute (NCI)

This project will develop a needle biopsy and needle localization device that can be used with existing mammographic equipment. Using a stereotactic algorithm, this equipment will enable an operator to place a needle into the breast for obtaining aspiration cytology samples or prior to open biopsy to place a localization wire within 1 to 2 mm in x, y, and z. Because this method utilizes a computer and does not require photographic development, the entire process could be performed in a few minutes.In Phase II, research will be directed toward the development of prototype hardware and software that are suitable for experimental use in a clinical environment. Critical components will be selected and studied with the view of developing a cost-effective device. The equipment will be tested on phantoms and patients to determine accuracy and ease of use compared with existing methodology.Awardee's statement of the potential commercial applications of the research:Equipment that could be used with existing x-ray mammography units that would facilitate needle localization prior to open biopsy and accurately place needles in the breast for aspiration or core biopsy would provide a significant improvement to current practice. The potential market is large as there are approximately 7,000 mammographic units in the United States.National Cancer Institute (NCI)