drugset / Trial / NCT04212793

Detection of PitNET Tissue During TSS Using Bevacizumab-800CW

NCT04212793 ↗

Phase 1 Completed 20 enrolled University Medical Center Groningen
Non-randomizedSequentialOpen-labelDiagnostic

Summary

There is a need for improved visualization of presence and extent of pituitary neuroendocrine tumor (PitNET) tissue during transsphenoidal surgery (TSS), especially in tumors invading the cavernous sinus (CS). Optical molecular imaging of PitNET associated biomarkers is a promising technique to accommodate this need. Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in PitNET tissue compared to normal pituitary tissue and has proven to be a valid target for molecular imaging. Bevacizumab is an antibody that binds VEGF-A. By conjugating a fluorescent dye to this antibody, the fluorescent tracer molecule bevacizumab-800CW is created, which binds to VEGF-A. The investigators hypothesize that bevacizumab-800CW accumulates in PitNET tissue, enabling visualization using a molecular fluorescence endoscopy system. In this pilot intervention study the investigators will determine the feasibility of using microdoses (4.5, 10 and 25 mg) of bevacizumab-800CW to detect PitNET tissue intraoperatively.

Timeline

Start
2020-10-28
Primary completion
2022-10-24
Completion
2022-10-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab-IRDye800CW Monoclonal antibody 4.5 mg Intravenous
Subject Bevacizumab-IRDye800CW Monoclonal antibody 10 mg Intravenous
Subject Bevacizumab-IRDye800CW Monoclonal antibody 25 mg Intravenous