Real-time Margin Assessment in Head and Neck Cancer

Inclusion Criteria:

• Cytology and/or histology-confirmed diagnosis of oral squamous cell carcinoma andscheduled to undergo surgical removal as decided by the multidisciplinary head andneck tumor board of the UMCG;

• Age ≥ 18 years;

• Written informed consent.

Exclusion Criteria:

• Medical or psychiatric conditions that compromise the patient's ability to giveinformed consent;

• Concurrent uncontrolled medical conditions;

• Received an investigational drug within 30 days prior to the dose ofcetuximab-800CW;

• History of myocardial infarction, cerebrovascular accident, uncontrolled cardiacheart failure, significant liver disease (ALT >3X upper limits of normal orincreased total bilirubin) or unstable angina within 6 months prior to enrollment;

• Inadequately controlled hypertension with or without current antihypertensivemedications;

• History of allergy or infusion reactions cetuximab or other monoclonal antibodytherapies;

• Pregnant or lactating women. Documentation of a negative pregnancy test must beavailable for women of childbearing potential. Moreover, the need to be willing toensure that she or her partner uses effective contraception during the trial and for 6 months thereafter. Woman of childbearing potential are premenopausal women withintact reproductive organs and women less than two years after menopause;

• Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males orgreater than 450 ms in females)

• Patients receiving Class 1a (quinidine, procainamide) or Class III (dofetilide,amiodarone, sotalol) antiarrhythmic agents.

• Life expectancy < 12 weeks;