SBIR-STTR Award

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. PROPOSED COMMERCIAL APPLICATIONS: 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.

The goal of breast conservation surgery is local control through complete tumor removal with minimal normal tissue excision. However, in about one-third of lumpectomies, specimen margins contain cancer cells, strongly suggesting the presence of residual cancer in the breast. These residual cells are the presumed etiology of local recurrence, and are typically treated with local therapy (e.g., re-excision or radiation) or systemic therapy. Intraoperative ultrasound has been used to reduce the incidence of positive lumpectomy margins. Since ultrasound does not typically detect in situ cancer (which is associated with positive lumpectomy margins in 40% of cases), intraoperative ultrasound is not likely to completely solve the problem of positive lumpectomy margins. We propose the use of image-guided surgery in which a novel high resolution dedicated breast positron emission tomography ("PET") scanner is used to define the location and extent of cancer prior to surgery. Published pilot data suggest that this high performance scanner (2.5 mm full-width half-maximum spatial resolution) can accurately define the size of breast cancers. A prospectively planned controlled clinical trial is proposed, involving 264 women scheduled for lumpectomy who are randomized into two groups of equal size. In the test group, subjects will have high resolution PET scans of the affected breast prior to surgery, with guide wires or markers placed as needed to specify the cancer extent and location. Follow-up reviews of pathology records will determine the fraction of patients with positive lumpectomy margins. Members of the control group of subjects will not receive PET scans, and will have their records reviewed as in the test group. Statistical considerations suggest that we are likely to observe (with 80% power) whether the percentage of patients with lumpectomy margins decreases by a factor of two (i.e. from 30% to 15%) when the results from perioperative PET scans are applied. Matching private funds are already committed for all phases of this SBIR project