drugset / Trial / NCT02743975

Near-infrared Image Guided Surgery in Pancreatic Adenocarcinoma

NCT02743975 ↗

NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2016-12-01
Primary completion
2018-02-26
Completion
2018-05-01

Outcome

Outcome not reported

Stopped: “Insufficient tumor-to-background ratios in the first three dose groups”

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab-800CW Diagnostic / imaging agent 4.5 mg —
Subject Bevacizumab-800CW Diagnostic / imaging agent 10 mg —
Subject Bevacizumab-800CW Diagnostic / imaging agent 25 mg —
Subject Bevacizumab-800CW Diagnostic / imaging agent 50 mg —