Real-time Margin Assessment in Head and Neck Cancer

Phase 2

Recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma; Head and Neck Cancer
• Interventions: Procedure: Fluorescence guided detection of tumor positive margins; Drug: Cetuximab-IRDye800

• Registration Number: NCT05499065
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-12
• Study Start: 2023-03-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-22
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Cytology and/or histology-confirmed diagnosis of oral squamous cell carcinoma and scheduled to undergo surgical removal as decided by the multidisciplinary head and neck tumor board of the UMCG;
• Age ≥ 18 years;
• Written informed consent.

Exclusion Criteria

• Medical or psychiatric conditions that compromise the patient's ability to give informed consent;
• Concurrent uncontrolled medical conditions;
• Received an investigational drug within 30 days prior to the dose of cetuximab-800CW;
• History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease (ALT >3X upper limits of normal or increased total bilirubin) or unstable angina within 6 months prior to enrollment;
• Inadequately controlled hypertension with or without current antihypertensive medications;
• History of allergy or infusion reactions cetuximab or other monoclonal antibody therapies;
• Pregnant or lactating women. Documentation of a negative pregnancy test must be available for women of childbearing potential. Moreover, the need to be willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter. Woman of childbearing potential are premenopausal women with intact reproductive organs and women less than two years after menopause;
• Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
• Patients receiving Class 1a (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
• Life expectancy < 12 weeks;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
75mg cetuximab + 15mg cetuximab-800CW	Fluorescence guided detection of tumor positive margins	To investigate if study drugs can assist in tumor-positive margin detection
75mg cetuximab + 15mg cetuximab-800CW	Cetuximab-IRDye800	To investigate if study drugs can assist in tumor-positive margin detection

Primary Outcome Measures

Name	Time	Method
Enhanced intra-operative margin detection	Postoperatively, i.e. 7-10 working days	To determine the feasibility of fluorescence imaging combined with fresh frozen sectioning of a fluorescence guided biopsy of the excised tissue specimen in an on-site intra-operative setting.; Outcome parameter: Detection rate of tumor-positive margins based on standard of care histopathological H/E assessment compared to fresh-frozen section analysis combined with fluorescence

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands