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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

Tracking Information
First Submitted Date  ICMJE April 11, 2016
First Posted Date  ICMJE April 19, 2016
Last Update Posted Date January 28, 2020
Actual Study Start Date  ICMJE December 1, 2016
Actual Primary Completion Date February 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2016)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2016)
Number of participants with treatment-related adverse events [ Time Frame: Up to 4 weeks after tracer injection ]
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 Near-infrared Image Guided Surgery in Pancreatic Adenocarcinoma
Official Title  ICMJE Intraoperative Detection of Cancer Tissue in Pancreatic Adenocarcinoma Using a VEGF-targeted Optical Fluorescent Imaging Tracer, A Multicentre Feasibility Dose Escalation Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
phase I/II safety and dose-finding study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Pancreatic Cancer
  • Pancreatic Adenocarcinoma
Intervention  ICMJE Drug: Bevacizumab-800CW
dose finding: 4.5mg; 10mg; 25mg; 50mg
Other Name: Bevacizumab-IRDye800CW
Study Arms  ICMJE Experimental: Treatment group
Bevacizumab-800CW
Intervention: Drug: Bevacizumab-800CW
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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 25, 2020)
10
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2016)
26
Actual Study Completion Date  ICMJE May 1, 2018
Actual Primary Completion Date February 26, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02743975
Other Study ID Numbers  ICMJE NL50488.042.15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party G.M. van Dam, University Medical Center Groningen
Study Sponsor  ICMJE University Medical Center Groningen
Collaborators  ICMJE Leiden University Medical Center
Investigators  ICMJE
Principal Investigator: Gooitzen van Dam, MD UMCG
PRS Account University Medical Center Groningen
Verification Date January 2020

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