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Trial record 2 of 532 for:    cholangiocarcinoma

Fluorescence Image Guided Surgery in Cholangiocarcinoma (COUGAR)

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ClinicalTrials.gov Identifier: NCT03620292
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
dr. W.B. Nagengast, MD, University Medical Center Groningen

Tracking Information
First Submitted Date  ICMJE June 11, 2018
First Posted Date  ICMJE August 8, 2018
Last Update Posted Date October 10, 2018
Estimated Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2018)
Optimal dose finding of Bevacizumab 800CW in hilar cholangiocarcinoma [ Time Frame: 24 months ]
- 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03620292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2018)
  • Peroperative detection of hilar cholangiocarcinoma with real-time near-infrared fluorescence camera [ Time Frame: 24 months ]
    - 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?
  • Detection of hilar cholangiocarcinoma in real-time near-infrared fluorescence ex-vivo endoscopy [ Time Frame: 24 months ]
    - 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?
  • Establish tracer distribution in tumour tissue [ Time Frame: 24 months ]
    - Visualisation of tracer distribution at microscopic level using ex vivo needle based confocal laser endomicroscopy.
  • Measurement of fluorescence in tumour tissue en surrounding normal tissue [ Time Frame: 24 months ]
    - Correction for scattering and measurement of fluorescent signal using spectroscopy ex vivo.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluorescence Image Guided Surgery in Cholangiocarcinoma
Official Title  ICMJE Cholangiocarcinoma Detection Using an Intraoperative Fluorescence Image Guided Approach With Bevacizumab-IRDye 800CW
Brief 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.

Detailed Description See brief summary
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Hilar Cholangiocarcinoma
Intervention  ICMJE
  • Drug: Bevacizumab-IRDye800CW
    Intravenous administration of Bevacizumab-IRDye800CW prior to surgery for hilar cholangiocarcinoma
    Other Name: Tracer administration
  • Device: near infrared (NIR) fluorescence imaging
    Intraoperative NIR fluorescence imaging of hilar cholangiocarcinoma, lymph nodes, resection margins, resection specimens
    Other Name: optical imaging
Study Arms  ICMJE Experimental: Intraoperative NIR fluorescence imaging

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
Interventions:
  • Drug: Bevacizumab-IRDye800CW
  • Device: near infrared (NIR) fluorescence imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 2, 2018)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2020
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with clinical suspicion of PHCC who are scheduled to undergo surgical intervention with curative intent
  • WHO performance score 0-2.

Exclusion Criteria:

  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
  • Other invasive malignancy
  • Pregnant or lactating women.
  • History of infusion reactions to bevacizumab or other monoclonal antibody therapies.
  • Inadequately controlled hypertension with or without current antihypertensive medications
  • Within 6 months prior to inclusion: myocardial infarction, TIA, CVA pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina pectoris.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: W B Nagengast, MD, PhD, PharmD +31503612620 w.b.nagengast@umcg.nl
Contact: A B de Vries, MD +31503612586 a.b.de.vries01@umcg.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03620292
Other Study ID Numbers  ICMJE NL65378.042.18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party dr. W.B. Nagengast, MD, University Medical Center Groningen
Study Sponsor  ICMJE University Medical Center Groningen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: G. M. van Dam, MD, PhD University Medical Center Groningen
Principal Investigator: M. T. de Boer, MD, PhD University Medical Center Groningen
Principal Investigator: W. B. Nagengast, MD, PhD, PharmD University Medical Center Groningen
PRS Account University Medical Center Groningen
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP