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Real-time Margin Assessment in Head and Neck Cancer

NCT05499065 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-05-31

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Floris J Voskuil, MD, PhD · University Medical Center Groningen

  • Max JH Witjes, MD, PhD · University Medical Center Groningen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-10-23
Completion
2025-01-10

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05499065 on ClinicalTrials.gov