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

Primary Purpose

Pancreatic Cancer, Pancreatic Adenocarcinoma

Status
Terminated
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Bevacizumab-800CW
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Medical Center Groningen
  • Leiden University Medical Center
  • Radboud University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

Bevacizumab-800CW

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Number of participants with treatment-related adverse events

Full Information

First Posted
April 11, 2016
Last Updated
January 25, 2020
Sponsor
University Medical Center Groningen
Collaborators
Leiden University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02743975
Brief Title
Near-infrared Image Guided Surgery in Pancreatic Adenocarcinoma
Acronym
PENGUIN
Official Title
Intraoperative Detection of Cancer Tissue in Pancreatic Adenocarcinoma Using a VEGF-targeted Optical Fluorescent Imaging Tracer, A Multicentre Feasibility Dose Escalation Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Insufficient tumor-to-background ratios in the first three dose groups
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
February 26, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
Collaborators
Leiden University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Pancreatic Adenocarcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
phase I/II safety and dose-finding study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Bevacizumab-800CW
Intervention Type
Drug
Intervention Name(s)
Bevacizumab-800CW
Other Intervention Name(s)
Bevacizumab-IRDye800CW
Intervention Description
dose finding: 4.5mg; 10mg; 25mg; 50mg
Primary Outcome Measure Information:
Title
Tracer accumulation in tumor tissue vs normal pancreatic tissue assessed by intraoperatively and ex vivo measuring of the mean fluorescent intensity
Description
Mean Fluorescent Intensity (MFI) measured in tumor tissue compared to normal pancreatic tissue at macroscopic and microscopic level
Time Frame
up to 6 months
Title
Finding optimal dose of Bevacizumab-800CW for intraoperative imaging of pancreatic cancer measured by calculating Target to Background ratios (TBR)
Description
TBR of each dose group assessed by intraoperative imaging as well as ex vivo imaging
Time Frame
3 days after tracer injection
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events
Time Frame
Up to 4 weeks after tracer injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gooitzen van Dam, MD
Organizational Affiliation
UMCG
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
Country
Netherlands
Facility Name
Radboud University Medical Center
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Near-infrared Image Guided Surgery in Pancreatic Adenocarcinoma

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