Fluorescence Image Guided Surgery in Cholangiocarcinoma
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
Cholangiocarcinoma is an epithelial cell malignancy arising from varying locations within the
biliary tree and is difficult to diagnose due to the often-silent clinical nature. The best
chance of long-term survival and potential cure is surgical resection with negative surgical
margins, but many patients are unresectable due to locally advanced or metastatic disease at
diagnosis. Because cholangiocarcinoma is difficult to diagnose at an early stage and extends
diffusely, most patients have unresectable disease at clinical presentation, and prognosis is
very poor (5-year survival is 0-40% even in resected cases)
There is a need for better visualization of tumor tissue, lymph nodes and resection margins
during surgery for perihilar cholangiocarcinoma (PHCC). Optical molecular imaging of PHCC
associated biomarkers is a promising technique to accommodate this need. The biomarkers
Vascular Endothelial Growth Factor (VEGF-A), Epidermal Growth Factor Receptor (EGFR) and
c-MET are all overexpressed in PHCC versus normal tissue and are proven to be valid targets
for molecular imaging. Currently, tracers that target these biomarkers are available for use
in clinical studies. In previous studies with other tumor types, the investigators tested the
tracer bevacizumab-IRDye800CW for the biomarker VEGF-A with very promising results. Since all
markers show roughly similar expression in ex vivo studies, the initial study will be
performed with bevacizumab-IRDye800CW as the investigators have the most experience with this
tracer. The investigators hypothesize that the tracer bevacizumab-IRDye 800CW accumulates in
PHCC tissue, enabling visualization using a NIR intraoperative camera system and ex vivo NIR
endoscopy. In this pilot study, the investigators will determine if it is possible to detect
PHCC intraoperatively and by ex vivo NIR endoscopy using bevacizumab 800CW, and which tracer
dose gives the best target-to-background ratio. The most optimal tracer dose will be selected
for a future phase II trial.