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Near-infrared Image Guided Surgery in Pancreatic Adenocarcinoma (PENGUIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02743975
Recruitment Status : Terminated (Insufficient tumor-to-background ratios in the first three dose groups)
First Posted : April 19, 2016
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
Leiden University Medical Center
Information provided by (Responsible Party):
G.M. van Dam, University Medical Center Groningen

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Pancreatic Adenocarcinoma Drug: Bevacizumab-800CW Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: phase I/II safety and dose-finding study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Intraoperative Detection of Cancer Tissue in Pancreatic Adenocarcinoma Using a VEGF-targeted Optical Fluorescent Imaging Tracer, A Multicentre Feasibility Dose Escalation Study
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : February 26, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment group
Bevacizumab-800CW
 Drug: Bevacizumab-800CW
dose finding: 4.5mg; 10mg; 25mg; 50mg
Other Name: Bevacizumab-IRDye800CW


Outcome Measures
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Primary Outcome Measures :
  1. Tracer accumulation in tumor tissue vs normal pancreatic tissue assessed by intraoperatively and ex vivo measuring of the mean fluorescent intensity [ Time Frame: up to 6 months ]
    Mean Fluorescent Intensity (MFI) measured in tumor tissue compared to normal pancreatic tissue at macroscopic and microscopic level

  2. Finding optimal dose of Bevacizumab-800CW for intraoperative imaging of pancreatic cancer measured by calculating Target to Background ratios (TBR) [ Time Frame: 3 days after tracer injection ]
    TBR of each dose group assessed by intraoperative imaging as well as ex vivo imaging


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: Up to 4 weeks after tracer injection ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743975


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Leiden University Medical Center
Leiden, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Sponsors and Collaborators
University Medical Center Groningen
Leiden University Medical Center
Investigators
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Principal Investigator: Gooitzen van Dam, MD UMCG
More Information
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Responsible Party: G.M. van Dam, Prof. Dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02743975    
Other Study ID Numbers: NL50488.042.15
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Bevacizumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors