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TerminatedNCT02743975PENGUINUpdated Jan 28, 2020

Near-infrared Image Guided Surgery in Pancreatic Adenocarcinoma

A Phase 1/2 interventional study of Bevacizumab-800CW in Pancreatic Cancer and Pancreatic Adenocarcinoma, sponsored by University Medical Center Groningen. Terminated at 3 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-28.

Sponsored by University Medical Center Groningen · Phase 1/2, Interventional, and Diagnostic

Why this study was terminated
Insufficient tumor-to-background ratios in the first three dose groups
Phase
Phase 1/2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

There is a need for better visualization of resection margins and detection of small tumor deposits during surgery for pancreatic cancer. Optical molecular imaging of pancreatic ductal adenocarcinoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in pancreatic cancer tissue versus normal tissue and has proven to be a valid target for molecular imaging. VEGF-A can be targeted by the monoclonal antibody bevacizumab. Monoclonal antibodies can be labeled by the near-infrared (NIR) fluorescent dye IRDye800CW (800CW). The investigators hypothesize that bevacizumab-800CW accumulates in VEGF expressing cancer, enabling pancreatic cancer visualization using a NIR intraoperative camera system. In this pilot intervention study the investigators will determine the optimal dosage of bevacizumab-800CW (4,5 10, 25 or 50mg) to detect pancreatic cancer tissue intraoperatively.

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Conditions studied

  • Pancreatic Cancer
  • Pancreatic Adenocarcinoma

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03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's enrollment of 10 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

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Lead sponsor

University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥ 18 years.
  • Patients with clinical suspicion of pancreatic head cancer who are scheduled to undergo surgical intervention with curative intent
  • World Health Organization (WHO) performance score 0-2.
  • Signed written informed consent

Exclusion criteria

Exclusion Criteria:

  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
  • Other invasive malignancy
  • Pregnant or lactating women. Documentation of a negative pregnancy test must be available for woman of childbearing potential. Woman of childbearing potential are pre- menopausal women with intact reproductive organs and women less than two years after menopause.
  • Prior neo-adjuvant chemo- of radiotherapy
  • 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, Transient Ischemic Attack, Cerebral Vascular Accident, pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina pectoris.
  • Anticoagulant therapy with vitamine K antagonists
  • Patients receiving Class 1A (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
  • Evidence of QTc (corrected QT interval) prolongation on pretreatment ECG (greater than 44ms in males of greater than 450ms in females)
  • Magnesium, potassium and calcium below the lower limit of normal range.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Treatment group

    Bevacizumab-800CW

    Drug: Bevacizumab-800CW

Interventions

  • DrugBevacizumab-800CW

    dose finding: 4.5mg; 10mg; 25mg; 50mg

    Also known as: Bevacizumab-IRDye800CW

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What researchers measure

Primary outcomes

  1. Tracer accumulation in tumor tissue vs normal pancreatic tissue assessed by intraoperatively and ex vivo measuring of the mean fluorescent intensity

    Mean Fluorescent Intensity (MFI) measured in tumor tissue compared to normal pancreatic tissue at macroscopic and microscopic level

    Time frame: up to 6 months

  2. Finding optimal dose of Bevacizumab-800CW for intraoperative imaging of pancreatic cancer measured by calculating Target to Background ratios (TBR)

    TBR of each dose group assessed by intraoperative imaging as well as ex vivo imaging

    Time frame: 3 days after tracer injection

Secondary outcomes

  1. Number of participants with treatment-related adverse events

    Time frame: Up to 4 weeks after tracer injection

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Study locations

3 sites
  • University Medical Center Groningen
    Groningen, 9713 GZ, Netherlands
  • Leiden University Medical Center
    Leiden, Netherlands
  • Radboud University Medical Center
    Nijmegen, Netherlands
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02743975
Lead sponsor
University Medical Center Groningen
Collaborators
Leiden University Medical Center
Responsible party
G.M. van Dam (Prof. Dr., University Medical Center Groningen) — Principal investigator
First posted
Apr 19, 2016
Start date
Dec 1, 2016
Primary completion
Feb 26, 2018
Completion
May 1, 2018
Last update
Jan 28, 2020

Study contacts

Gooitzen van Dam, MD
principal investigator · UMCG

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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