Image guided surgery for margin assessment of squamous cell carcinoma during Mohs micrographic surgery: a phase I proof of concept study
- Conditions
- Cutaneous squamous cell carcinoma
- Registration Number
- NL-OMON23751
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
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.
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%.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Macroscopic fluorescent signal levels (TBR) and tracer distribution observed by NIR<br>fluorescence imaging using the intraoperative in vivo imaging as well as the ex vivo backtable<br>imaging;<br>- Quantification of fluorescent signals using MDSFR/SFF spectroscopy;<br>- Standard histopathological assessment (i.e. haematoxylin and eosin staining) to correlate<br>fluorescent and non-fluorescent areas detected in vivo with histology using surgical<br>specimen;
- Secondary Outcome Measures
Name Time Method - Histopathologic examinations related to ex vivo EGFR expression and cetuximab-<br>IRDyeCW800 distribution.<br>- Quantification of the cetuximab-800CW optoacoustic signal and the tracer distribution<br>observed by multispectral optoacoustic imaging using the MSOT Acuity Echo in vivo.