Image guided surgery for margin assessment of cutaneous squamous cell carcinoma during surgery: a phase I proof of concept study
- Conditions
- skin cancer10040900
- Registration Number
- NL-OMON49316
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
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.
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 <p>- Macroscopic fluorescent signal levels (TBR) and tracer distribution observed<br /><br>by NIR fluorescence imaging using the intraoperative in vivo imaging as well as<br /><br>the ex vivo back-table imaging;<br /><br>- Quantification of fluorescent signals using MDSFR/SFF spectroscopy;<br /><br>- Standard histopathological assessment (i.e. haematoxylin and eosin staining)<br /><br>to correlate fluorescent and non-fluorescent areas detected in vivo with<br /><br>histology using surgical specimen;</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Patient characteristics (age, sex, BMI, history and morbidity, localization<br /><br>and classification of cancer, treatment outcome, blood pressure, pulse and<br /><br>temperature before and after tracer administration, signs and symptoms before<br /><br>and after tracer administration).<br /><br>- Histopathologic examinations related to ex vivo EGFR expression and<br /><br>cetuximab-IRDyeCW800 distribution.<br /><br>- Quantification of the cetuximab-800CW optoacoustic signal and the tracer<br /><br>distribution observed by multispectral optoacoustic imaging using the MSOT<br /><br>Acuity Echo in vivo.</p><br>