Near-infrared Image Guided Surgery in Pancreatic Adenocarcinoma

• Status: Terminated
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborator: Leiden University Medical Center
• Treatments: Bevacizumab

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.