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

University Medical Center Groningen (UMCG)

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Pancreatic Adenocarcinoma

Pancreatic Cancer

Treatments

Drug: Bevacizumab-800CW

Study type

Interventional

Funder types

Other

Identifiers

NCT02743975

NL50488.042.15

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.