Real-time Margin Assessment in Head and Neck Cancer

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

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

Conditions
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Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Procedure: Fluorescence guided detection of tumor positive margins
* Drug: Cetuximab-IRDye800


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 75mg cetuximab + 15mg cetuximab-800CW<br>To investigate if study drugs can assist in tumor-positive margin detection | Procedure: Fluorescence guided detection of tumor positive margins<br>* To test if the fluorescence can guide the location for fresh frozen section sampling intra-operatively<br>Drug: Cetuximab-IRDye800<br>* Administrate 75mg cetuximab + 15mg cetuximab-800CW for fluorescence visualization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enhanced intra-operative margin detection | 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 | Postoperatively, i.e. 7-10 working days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluorescence guided surgery, Cetuximab-800CW