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
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Application of peptide to 25 subjects undergoing colonoscopy
To evaluate the safety of topically administered fluorescence-labeled peptides to the surface of intra-colonic mucosa.
Danielle Kim Turgeon, M.D.
University of Michigan
United States: Food and Drug Administration
|University of Michigan||Ann Arbor, Michigan 48109-0624|