Optimal surgical treatment of tumors requires complete tumor excision with -minimal removal of surrounding normal tissue. This can be difficult with nonpalpable cancer, since the surgeon and pathologist cannot directly visualize the border between tumor cells and normal surrounding tissue. Thanks to increased utilization of mammographic services, the percentage of cancers detected at the nonpalpable stage is increasing. This phase I SBIR will test and refine a novel product for imaging surgical specimens from cancer patients. The final product is intended to provide useful information to the pathologist, while the patient is stifi in the operating room. A pilot clinical study to identify cancer foci in specimen sections has shown promising results. For the Phase I portion of this project, we will use the product to approximate the closest distance between cancer cells and the specimen margin. This distance of dosest approach is a strong determinant of patient management and prognosis. The predicted distance will be compared to final pathological determinations. This novel imaging method has strong potential to improve the practice of surgical pathology by permitting a more timely assessment of complete tumor excision, which will lead to improved survival and better post-operative cosmetic results. Provide key words (8 maximum) to identify the research or technology.
An integrated imaging device, tested and refined through this SBIR, will be marketed as a cost-effective workstation that can assist the pathologist in rapidly identifying areas of cancer in surgical specimens. No comparable devices exist. The total market potential is greater than $500 million.
