A Phase 1B In-Vivo Esophageal Protocol for Detection of Neoplasia in the Digestive Tract
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
validate binding of the fluorescent-labeled peptide to esophageal neopla
The overall aim of this research project is to develop the use of fluorescent-labeled peptides that affinity bind to pre-cancerous mucosa in the digestive tract for use as an imaging agent to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This particular study is a phase Ib, vaidation of efficacy of the topically applied peptide and continuing assessment of safety. To validate binding of the fluorescent-labeled peptide to esophageal neoplasia using an Olympus FITC Endoscopic Molecular Imaging System.
Danielle Kim Turgeon, M.D.
University of Michigan
United States: Food and Drug Administration
|University of Michigan||Ann Arbor, Michigan 48109-0624|