skin cancer
Conditions
Interventions
Patients will * after written informed consent * receive an intravenous
injection of the predose unlabeled cetuximab (after clemastine administration)
and one hour later the fluorescent tracer Cetux
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Biopsy confirmed diagnosis of cSCC and scheduled to undergo surgical resection; 2) Age * 18 years; 3) Written informed consent; 4) Mentally competent person showing adequate potential for follow-up; For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal: 5) A negative serum or urine pregnancy test prior to receiving the tracer. 6) Willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter.
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) Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females); 9) Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents; 10) Magnesium, potassium and calcium deviations that might lead to cardiac rhythm (grade II or higher deviations by CTCAE). 11) Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Macroscopic fluorescent signal levels (TBR) and tracer distribution observed by NIR fluorescence imaging using the intraoperative in vivo imaging as well as the ex vivo back-table imaging; - Quantification of fluorescent signals using MDSFR/SFF spectroscopy; - Standard histopathological assessment (i.e. haematoxylin and eosin staining) to correlate fluorescent and non-fluorescent areas detected in vivo with histology using surgical specimen; | — |
Secondary
| Measure | Time frame |
|---|---|
| - Patient characteristics (age, sex, BMI, history and morbidity, localization and classification of cancer, treatment outcome, blood pressure, pulse and temperature before and after tracer administration, signs and symptoms before and after tracer administration). - Histopathologic examinations related to ex vivo EGFR expression and cetuximab-IRDyeCW800 distribution. - Quantification of the cetuximab-800CW optoacoustic signal and the tracer distribution observed by multispectral optoacoustic imaging using the MSOT Acuity Echo in vivo. | — |
Countries
Netherlands
Outcome results
None listed