squamous cell carcinoma
Conditions
Interventions
Tracer administration: patients will visit the hospital four days prior to the
planned surgery of their HNSCC. The cetuximab-IRDye800CW will be injected by
slow infusion and patients will be monitor
EGFR
Fluorescence
head & neck cancer
Near Infrared tracer
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1) Biopsy confirmed diagnosis of primary or recurrent HNSCC and scheduled to undergo surgical resection as decided by the Multi-Disciplinary Head & Neck Tumor Board of the UMCG. 2) Age * 18 years 3) Written informed consent 4) Adequate potential for follow up 5) Acceptable hematologic status, kidney function, and liver function, as standard surgery protocol requires.
Exclusion criteria
Exclusion criteria: 1) Medical or psychiatric conditions that compromise the patient*s ability to give informed consent 2) Concurrent uncontrolled medical conditions. 3) Received an investigational drug within 30 days prior to the dose of cetuximab-IRDye800CW 4) Tumors at sites of which the surgeon would assess that in vivo imaging would not be feasible 5) Had within 6 months prior to enrollment: myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease, unstable angina 6) Inadequately controlled hypertension with or without current antihypertensive medications. 7) History of infusion reactions to cetuximab or other monoclonal antibody therapies 8) 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. 9) Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females) 10) Lab values that in the opinion of the primary surgeon would prevent surgical resection 11) Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. 12) Magnesium, potassium and calcium deviations that might lead to cardiac rhythm (grade II or higher deviations by CTCAE). 13) Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective Part 1 (dose finding) To determine the optimal dose of cetuximab-IRDye800CW for intra operative imaging with the SurgVision F2 open air NIRF imaging system of easily accessible anatomical areas in the head & neck region, or with a standard nasopharyngeal endoscope coupled to the SurgVision F2 NIRF imaging system for difficult accessible anatomical areas in the head & neck region. Primary objective Part 2 (main study) The main purpose is to establish the intraoperative use of cetuximab-IRDye800CW as a reliable marker for residual tumor in resection margins after surgical removal of HNSCC. The objective is to establish the positive predictive value of cetuximab-IRDye800CW fluorescence as a marker for a tumor positive resection margin. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the threshold level in vivo of cetuximab-IRDye800CW fluorescence for reliable intraoperative deep margins assessment with high sensitivity while ensuring an adequate positive predictive value. To quantify sensitivity and positive predictive value of cetuximab-IRDye800CW fluorescence of HNSCC ex vivo using optical molecular imaging and MDSFR/SFF versus fluorescence microscopy and EGFR immunohistochemistry. To obtain information on safety aspects of cetuximab-IRDye800CW administration by registration of conjugate blood levels, conjugate integrity, side effects, adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR). | — |
Countries
The Netherlands
Outcome results
None listed