Near-infrared Image Guided Surgery in Pancreatic Adenocarcinoma (PENGUIN)
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pancreatic Cancer Pancreatic Adenocarcinoma | Drug: Bevacizumab-800CW | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
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 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment group
Bevacizumab-800CW
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Drug: Bevacizumab-800CW
dose finding: 4.5mg; 10mg; 25mg; 50mg
Other Name: Bevacizumab-IRDye800CW |
- 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
- Number of participants with treatment-related adverse events [ Time Frame: Up to 4 weeks after tracer injection ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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.

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
Netherlands | |
University Medical Center Groningen | |
Groningen, Netherlands, 9713 GZ | |
Leiden University Medical Center | |
Leiden, Netherlands | |
Radboud University Medical Center | |
Nijmegen, Netherlands |
Principal Investigator: | Gooitzen van Dam, MD | UMCG |
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 |
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 |