NCT05499065

Real-time Margin Assessment in Head and Neck Cancer

Real-time Margin Assessment in Head and Neck Cancer - Enhancing Specificity by Combining Fresh Frozen Sectioning With Targeted Fluorescence Imaging

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate if the combination of fresh frozen sectioning based on cetuximab-800CW can enhance tumor-positive margin detection intra-operatively.

Conditions

• Head and Neck Cancer
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Fluorescence guided detection of tumor positive margins	To test if the fluorescence can guide the location for fresh frozen section sampling intra-operatively
DRUG	Cetuximab-IRDye800	Administrate 75mg cetuximab + 15mg cetuximab-800CW for fluorescence visualization

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-10-23
• Completion: 2025-01-10
• First posted: 2022-08-12
• Last updated: 2025-05-31

Locations

1 site across 1 country: Netherlands