The goal of this SBIR R&D program is to commercialize a diagnostic spectrofluorimeter (DSF) for use by gastroenterologists performing endoscopic screening and surveillance for colorectal dysplasia/carcinoma. The DSF will consist of a compact, special purpose spectrofluorimeter and a specially designed optical fiber diagnostic probe. The probe is passed through the biopsy channel of a standard colonoscope and brought into contact with the colonic mucosa. The DSF will excite, collect and analyze mucosal autofluorescence to indicate the presence of dysplasia. It will guide biopsy and enable real-time spectroscopic assessment of tissue suspected of being dysplastic. An innovative probe design allows spectroscopic readings followed by excision of a sample from the same location with the same probe. The objective of the Phase I effort was a design effort to accomplish (1) subsystem optimization, (2) system optimization and (3) prototype design of an integrated, Compact, easy-to- use prototype unit which would be constructed and clinically tested in a Phase II effort. All goals were met. The Phase II effort will continue by (l) making a whole DSF instrument system, (2) characterizing its performance, (3) improving the design, and (4) clinically testing it on 65 patients at the Lahey Clinic. The program will continue to employ background knowledge and technology developed at MIT under NIH support. Innovation in this project will come in areas of system design, engineering, and construction with respect to being clinically attractive and inexpensive enough to improve the standard of care while lowering costs.
The commercial applications of the proposed diagnostic spectrofluorimeter (DSF) are of great potential importance. Each year in the United States there are approximately 151,000 cases of colorectal cancer, with 61,000 deaths. Currently, the annual number of cancer-related colorectal procedures in the US. is in excess of 600,000. There is an enormous need for improved screening methods, particularly for early stage colorectal disease. The DSF would provide such a method. The technology developed as a result of this SBIR grant is also potentially applicable to detection of dysplasia elsewhere in the GI tract (e.g. esophagus and stomach), as well as in other organs, such as the urinary bladder, the cervix and gynecological tract, and the skin. There is also an enormous need for improved methods for screening for superficial neoplasia/dysplasia in these organs. Current data from the US. National Center for Health Statistics indicates that the number of world- wide diagnostic procedures for cancer in these organs is approximately 10 million per year, with the colon, rectum and recto-sigmoid representing about a quarter of this total.
