cancer of unknown primary head & neck cancer
Conditions
Interventions
Patients will - after written informed consent - receive an intravenous
injection of the fluorescent tracer. Two days later, panendoscopy will be
performed.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Cytology confirmed diagnosis of squamous cell carcinoma and scheduled to undergo panendoscopy as decided by the Multi-Disciplinary Head and Neck Tumor Board of the UMCG; - The primary tumor was not identified during standard diagnostic work-up in the outpatient clinic including physical head and neck examination, laryngoscopy, X-thorax and CT, PET or MRI; - Age >= 18 years; - Written informed consent; - Mentally competent person that is able and willing to comply with study procedures.
Exclusion criteria
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; - History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease or unstable angina within 6 months prior to enrollment; - 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); - Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents; - Clinically significant abnormalities in magnesium, potassium and calcium levels; - Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Macroscopic fluorescent signal levels (TBR) and tracer distribution observed by molecular fluorescence imaging using the multispectral F2 camera system; - Number and extension of detected lesions with (pre)malignant vascular patterns. - Standard histopathological assessment (i.e. hematoxylin and eosin staining) to correlate fluorescent and non-fluorescent areas detected in vivo with histology using in vivo obtained biopsies; - EGFR expression by means of EGFR immunohistochemistry. | — |
Secondary
| Measure | Time frame |
|---|---|
| See above | — |
Countries
Netherlands
Outcome results
None listed