drugset / Trial / NCT03925285

Image Guided Surgery in Sinonasal Inverted Papilloma

NCT03925285 ↗

Phase 1 Unknown 6 enrolled University Medical Center Groningen
NaSingle-groupOpen-labelDiagnostic

Summary

In sinonasal inverted papilloma (SNIP) it is very challenging to discriminate between tumor and surrounding tissue. Local recurrence is a frequent phenomenon as it occurs in 16.5% of the cases. There is need for an instrument that is able to guide the surgeon in removing all tumor tissue, whereas resection of healthy tissue is minimalized. Molecular fluorescence guided surgery enables the visualization of targeted tumor-specific biomarkers by using fluorescence, thereby enhancing the contrast between normal mucosa and tumor tissue. The objective of this feasibility study is to determine if the intravenously administered conjugate bevacizumab-IRDye800CW accumulates more in SNIP than in normal sinonasal epithelium.

Timeline

Start
2019-05-06
Primary completion
2021-07-01
Completion
2022-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab-800CW Diagnostic / imaging agent 10 mg Intravenous
Subject Bevacizumab-800CW Diagnostic / imaging agent 25 mg Intravenous

Indications