Fluorescence Intraoperative Surgical Margin Analysis in Head and Neck Cancer: Clinical Validation

Condition studied

oral squamous cell carcinoma

Investigational medicinal product(s)

Eligibility

Primary endpoint

Compare surgical outcome in terms of margin status between the intervention cohort and the standard of care cohort

Endpoint detail

Determining diagnostic parameters (including predictive values, sensitivity, specificity, type I & II errors) of fluorescence imaging for identifying inadequate tumor margins., Implementation of an intraoperative feedback workflow between the pathology department and surgery team on the margin assessment by FI., Retrospective comparison between standard fluorescence imaging devices and a novel technique using dual aperture fluorescence imaging as an exploratory objective.