A Phase 1/2 interventional study of Bevacizumab-IRDye800CW and near infrared (NIR) fluorescence imaging in Hilar Cholangiocarcinoma, sponsored by University Medical Center Groningen. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by University Medical Center Groningen · Phase 1/2, Interventional, and Diagnostic
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.
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This study's planned enrollment of 12 is below the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.
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Exclusion Criteria:
A non-randomized, non-blinded, prospective, single center pilot dose escalation study with bevacizumab-800CW for NIR fluorescence image guided surgery in hilar cholangiocarcinoma * IV-administration of 10, 25 or 50 mg of the fluorescent tracer bevacizumab-800CW to a total of 15 patients with resectable hilar cholangiocarcinoma 3 days prior to surgery. * Peroperative open air NIR fluorescence imaging * Ex vivo endoscopic and histopathological NIR fluorescence imaging
Drug: Bevacizumab-IRDye800CW · Device: near infrared (NIR) fluorescence imaging
Intravenous administration of Bevacizumab-IRDye800CW prior to surgery for hilar cholangiocarcinoma
Also known as: Tracer administration
Intraoperative NIR fluorescence imaging of hilar cholangiocarcinoma, lymph nodes, resection margins, resection specimens
Also known as: optical imaging
Optimal dose finding of Bevacizumab 800CW in hilar cholangiocarcinoma
- Comparison of three doses of Bevacizumab 800CW by calculating target to background ratios in fluorescence images obtained during and directly after the surgical procedure and fluorescence images obtained during ex vivo analyses in bread loaf slices and in histological slices (odyssey scanner, fluorescence microscopy).
Time frame: 24 months
Peroperative detection of hilar cholangiocarcinoma with real-time near-infrared fluorescence camera
- Comparison between perioperative fluorescent imaging and ex vivo analysis (histology, breadloaf slices) to see if detection of tumor tissue is feasible. I.e. is high fluorescent signal corresponding with localization of tumor tissue in ex-vivo analysis?
Time frame: 24 months
Detection of hilar cholangiocarcinoma in real-time near-infrared fluorescence ex-vivo endoscopy
- Comparison of endoscopic fluorescent imaging and ex vivo analysis(histology, breadloaf slices) to see if endoscopic detection is feasible. I.e. is high fluorescent signal seen during ex-vivo endoscopy corresponding with localization of tumor tissue in ex-vivo analysis?
Time frame: 24 months
Establish tracer distribution in tumour tissue
- Visualisation of tracer distribution at microscopic level using ex vivo needle based confocal laser endomicroscopy.
Time frame: 24 months
Measurement of fluorescence in tumour tissue en surrounding normal tissue
- Correction for scattering and measurement of fluorescent signal using spectroscopy ex vivo.
Time frame: 24 months
Plan to share: No
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University Medical Center Groningen