? This Small Business Innovation Research Phase I proposes the utilization of an in-vivo optical imaging system for tumor detection and localization during a laparoscopic surgery of ovarian cancer patients. Preliminary results using a prototype system demonstrated the effectiveness of folate-fluorescein to target specific tissues that express the receptor which is contained in greater than 90% of the ovarian cancers. The difference in fluorescence was very discernable. Tumors smaller than 1mm in size were noticeably fluorescent compared to background, thus the folate-fluorescein facilitated the detection of tumor tissues that were not detectable by direct observation, and would not be detectable by computed tomography (CT). Thus this technology is potentially a powerful and effective tool for monitoring patients with small volume ovary cancer with rising CA 125 levels after they have completed their primary surgery and chemotherapy. The need for such a technology is critical, since half of the patients who have advanced disease will suffer a recurrence in the first several years following completion of their primary therapy and the first sign of that recurrence is a rising CA 125 levels. At present, the CT imaging technology of choice is not sufficiently sensitive to detect tumors with a CA 125 level < 100 U/ml, or tumors smaller than about 1 cm. The primary aims of this Phase I proposal are i) to test the validity of this technology as an endoscopic fluorescent tumor imaging method and ii) to verify that human ovarian cancer tissues over-express the folate receptor. Thus this Phase I project is the basis for subsequent human medical trials to be carried out at the Indiana University Medical School in Phase II. ? ?
