Cutaneous squamous cell carcinoma
Conditions
Interventions
Intravenous injection of an unlabeled predose (cetuximab) and cetuximab-IRDye800CW two days prior to surgery. During surgery, fluorescence imaging will be performed.
Sponsors
University Medical Center Groningen
Eligibility
Inclusion criteria
Inclusion criteria: 1) Biopsy confirmed diagnosis of cSCC and scheduled to undergo surgical resection using MMS; 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 < 26 weeks; 12) Karnofsky performance status < 70%.
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 backtable 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 |
|---|---|
| - 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. | — |
Contacts
Public ContactJasper Vonk
University Medical Center Groningen
Outcome results
None listed