drugset / Trial / NCT02113202

Molecular Fluorescence Endoscopy in Patients With Familial Adenomatous Polyposis, Using Bevacizumab-IRDye800CW

NCT02113202 ↗

Phase 1 Completed 17 enrolled University Medical Center Groningen
Non-randomizedParallel-groupOpen-labelDiagnostic

Summary

There is a need for better visualization of polyps during surveillance endoscopy in patients with hereditary colon cancer syndromes like Familial Adenomatous Polyposis (FAP) and Lynch Syndrome (LS), to improve the adenoma detection rate. Optical molecular imaging of adenoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF) is overexpressed in adenomatous colon tissue versus normal tissue and has proven to be a valid target for molecular imaging. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye IRDye800CW. The investigators hypothesize that when bevacizumab-IRDye800CW is administered to patients, it accumulates in VEGF expressing adenomas, enabling adenoma visualization using a newly developed near-infrared (NIR) fluorescence endoscopy platform (NL43407.042.13). This hypothesis will be tested in this feasibility study, next to the determination of the optimal tracer dose.

Timeline

Start
2014-03
Primary completion
2015-10
Completion
2015-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab-IRDye800CW Monoclonal antibody 4.5 mg Intravenous
Subject Bevacizumab-IRDye800CW Monoclonal antibody 10 mg Intravenous
Subject Bevacizumab-IRDye800CW Monoclonal antibody 25 mg Intravenous