Near-infrared Image Guided Surgery in Pancreatic Adenocarcinoma
- Conditions
- Pancreatic CancerPancreatic Adenocarcinoma
- Interventions
- Registration Number
- NCT02743975
- Lead Sponsor
- University Medical Center Groningen
- 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 available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment group Bevacizumab-800CW Bevacizumab-800CW
- Primary Outcome Measures
Name Time Method Tracer accumulation in tumor tissue vs normal pancreatic tissue assessed by intraoperatively and ex vivo measuring of the mean fluorescent intensity 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) 3 days after tracer injection TBR of each dose group assessed by intraoperative imaging as well as ex vivo imaging
- Secondary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events Up to 4 weeks after tracer injection
Trial Locations
- Locations (3)
Radboud University Medical Center
🇳🇱Nijmegen, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands