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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522027-95-00
Enrollment
120
Registered
2026-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

oral squamous cell carcinoma

Brief summary

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

Detailed description

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.

Interventions

DRUGCETUXIMAB

Sponsors

Universitair Medisch Centrum Groningen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026