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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02743975 |
|
Recruitment Status :
Recruiting
First Posted : April 19, 2016
Last Update Posted : October 27, 2017
|
Sponsor:
University Medical Center Groningen
Collaborator:
Leiden University Medical Center
Information provided by (Responsible Party):
G.M. van Dam, University Medical Center Groningen
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 26 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 |
| Study Start Date : | September 2016 |
| Estimated Primary Completion Date : | March 2018 |
| Estimated Study Completion Date : | March 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Pancreatic Cancer
Drug Information available for:
Bevacizumab
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Treatment group
Bevacizumab-800CW
|
Drug: Bevacizumab-800CW
dose finding: 4.5mg; 10mg; 25mg; 50mg
Other Name: Bevacizumab-IRDye800CW |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Number of participants with treatment-related adverse events [ Time Frame: Up to 4 weeks after tracer injection ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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.
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
Contacts
| Contact: Gooitzen van Dam, MD | 0031 50 3610183 | g.m.van.dam@umcg.nl |
Locations
| Netherlands | |
| University Medical Center Groningen | Recruiting |
| Groningen, Netherlands, 9713 GZ | |
| Contact: Go M. van Dam, MD, PhD +31 50 361 0183 g.m.van.dam@umcg.nl | |
| Principal Investigator: Go M. van Dam, MD, PhD | |
| Leiden University Medical Center | Recruiting |
| Leiden, Netherlands | |
| Contact: Alex Vahrmeijer, MD 0031715269111 a.l.vahrmeijer@lumc.nl | |
| Radboud University Medical Center | Active, not recruiting |
| Nijmegen, Netherlands | |
Sponsors and Collaborators
University Medical Center Groningen
Leiden University Medical Center
Investigators
| Principal Investigator: | Gooitzen van Dam, MD | UMCG |
| Responsible Party: | G.M. van Dam, Prof. Dr., University Medical Center Groningen |
| ClinicalTrials.gov Identifier: | NCT02743975 History of Changes |
| Other Study ID Numbers: |
NL50488.042.15 |
| First Posted: | April 19, 2016 Key Record Dates |
| Last Update Posted: | October 27, 2017 |
| Last Verified: | October 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Additional relevant MeSH terms:
|
Adenocarcinoma Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases |
Pancreatic Diseases Endocrine System Diseases Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |