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Hilar CholangiocarcinomaPhase 1/2COUGARNCT03620292

Fluorescence Image Guided Surgery in Cholangiocarcinoma

A Phase 1/2 study testing Bevacizumab-IRDye800CW and near infrared (NIR) fluorescence imaging in people with Hilar Cholangiocarcinoma, run by University Medical Center Groningen at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hilar Cholangiocarcinoma
What is being tested?
Bevacizumab-IRDye800CW and near infrared (NIR) fluorescence imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteNetherlands
Study dates
1 Apr 2019to 1 Dec 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

W B Nagengast, MD, PhD, PharmD contact

+31503612620

w.b.nagengast@umcg.nl

A B de Vries, MD contact

+31503612586

a.b.de.vries01@umcg.nl

Netherlands1 site, 1 recruiting

  • University Medical Center Groningen

    Groningen, 9713 GZ

    W. B. Nagengast, MD, PhD, PharmD, +31503612620, w.b.nagengast@umcg.nl

    A. B. de Vries, MD, +31503612586, a.b.de.vries01@umcg.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Cholangiocarcinoma Detection Using an Intraoperative Fluorescence Image Guided Approach With Bevacizumab-IRDye 800CW

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.

Read the detailed description

See brief summary

Being tested
Bevacizumab-IRDye800CW, near infrared (NIR) fluorescence imaging
Medical subject headings
Klatskin Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevacizumab-IRDye800CWDrug

    Also called Tracer administration

    Intravenous administration of Bevacizumab-IRDye800CW prior to surgery for hilar cholangiocarcinoma

  • near infrared (NIR) fluorescence imagingDevice

    Also called optical imaging

    Intraoperative NIR fluorescence imaging of hilar cholangiocarcinoma, lymph nodes, resection margins, resection specimens

Study groups in NCT03620292
Study groupRoleWhat they receive
Intraoperative NIR fluorescence imagingExperimentalA 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
Receives: Drug: Bevacizumab-IRDye800CW; Device: near infrared (NIR) fluorescence imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 24 months

Secondary outcomes (4)

  1. 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?

    Measured: 24 months

  2. 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?

    Measured: 24 months

  3. Establish tracer distribution in tumour tissue

    • Visualisation of tracer distribution at microscopic level using ex vivo needle based confocal laser endomicroscopy.

    Measured: 24 months

  4. Measurement of fluorescence in tumour tissue en surrounding normal tissue

    • Correction for scattering and measurement of fluorescent signal using spectroscopy ex vivo.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2018
  2. Study start1 Apr 2019
  3. Primary completion1 Dec 2021 (estimated)
  4. Study completion1 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03620292
Sponsor's protocol ID
NL65378.042.18
Acronym
COUGAR
Status last verified
Apr 2021
First submitted
11 Jun 2018
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Bevacizumab-IRDye800CW and near infrared (NIR) fluorescence imaging in people with Hilar Cholangiocarcinoma, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact W B Nagengast, MD, PhD, PharmD (+31503612620, w.b.nagengast@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Optimal dose finding of Bevacizumab 800CW in hilar cholangiocarcinoma (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03620292.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.

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