A Phase I In-Vivo Colon Protocol for Detection of Neoplasia in the Digestive Tract (U54)

The goal of this research is to develop the use of fluorescence-labeled peptides (Colon KCC) that affinity bind to pre-cancerous mucosa in the digestive tract for use as an imaging agent to aid in the early detection of colon cancer. Currently colon cancer prevention is achieved by endoscopic evaluation and removal of pre-malignant lesions (adenomatous polyps) by endoscopic resection and biopsy. Standard endoscopy uses white light illumination and is only able to detect pre-cancerous tissue that has abnormal architectural features, such as a polyp or mass. However, pre-cancerous lesions can also be flat in appearance and visually indistinct from normal tissue; such as in the case of chronic ulcerative colitis and / or some right-sided polyps.

Furthermore, flat and depressed lesions, which are more difficult to detect in white light colonoscopy, may represent over 25% of all pre-malignant lesions and may confer a higher risk for malignancy. Integration of molecular probes that home in to diseased tissues with high resolution imaging instruments could greatly improve the diagnostic accuracy for missed lesions of both polypoid and non-polypoid morphology, including the often fatal 'right-sided ' adenomas.

Endoscopic imaging with the use of fluorescent-labeled probes is a promising method for achieving greater specificity, spatial localization and higher image contrast in the detection of neoplastic lesions. This study is a 'first-in-humans' test of the safety of the topically applied peptide.

A Phase I study of the safety of a topically-administered fluorescent heptapeptide for detecting neoplastic areas of the colon is proposed. The study will test the safety of administering this agent to human subjects undergoing clinically-indicated colonoscopy. Safety is defined as the occurrence of adverse events after the administration of topical fluorescence-labeled peptides to the surface of intra-colonic mucosa.