Image guided surgery for margin assessment of squamous cell carcinoma during Mohs micrographic surgery: a phase I proof of concept study

niversity Medical Center Groningen0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•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
•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
•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%.

发起方