Image Guided Surgery for Margin Assessment of Head and Neck Cancer Using Cetuximab-IRDye800CW cONjugate (ICON)
Head and Neck Squamous Cell Carcinoma, Margin Assessment
About this trial
This is an interventional diagnostic trial for Head and Neck Squamous Cell Carcinoma focused on measuring Intraoperative fluorescence imaging, Cetuximab-IRDye800CW, Molecular imaging
Eligibility Criteria
Inclusion criteria
- Biopsy confirmed diagnosis of primary or recurrent HNSCC and scheduled to undergo surgical resection as decided by the Multi-Disciplinary Head and Neck Tumor Board of the UMCG.
- Age ≥ 18 years
- Written informed consent
- Adequate potential for follow up
- Acceptable hematologic status, kidney function, and liver function, as standard surgery protocol requires.
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-IRDye800CW
- Tumors at sites of which the surgeon would assess that in vivo imaging would not be feasible
- Had within 6 months prior to enrollment: myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease, unstable angina
- Inadequately controlled hypertension with or without current antihypertensive medications.
- History of infusion reactions to cetuximab or other monoclonal antibody therapies
- Pregnant or lactating women. Documentation of a negative pregnancy test must be available for women of childbearing potential. 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)
- Lab values that in the opinion of the primary surgeon would prevent surgical resection.
- Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- Magnesium, potassium and calcium lower than the lower limit of normal range.
- Life expectancy < 12 weeks
- Karnofsky performance status < 70%
Sites / Locations
- University Medical Center GroningenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Phase 1: 10mg Cetuximab-IRDye800CW
Phase 1: 25mg Cetuximab-IRDye800CW
Phase 1: 50 mg Cetuximab-IRDye800CW
Phase 1: 75mg cetuximab + 15 mg Cetuximab-IRDye800CW
Phase 1: 75mg cetuximab + 25 mg Cetuximab-IRDye800CW
After having established the optimal cetuximab-IRDye800CW dose
Three patients will receive 10mg Cetuximab-IRDye800cv I.V. four days prior to surgery.
Patients will receive 25mg Cetuximab-IRDye800cv I.V. four days prior to surgery.
Patients will receive 50mg Cetuximab-IRDye800cv I.V. four days prior to surgery.
Patients will receive 75mg cetuximab + 15 mg Cetuximab-IRDye800CW I.V. four days prior to surgery.
Patients will receive 75mg cetuximab + 25 mg Cetuximab-IRDye800CW I.V. four days prior to surgery.
After having established the optimal cetuximab-IRDye800CW dose we will extent the study by including up to 70 patients for this specific dose (as determined in phase 1).