NL-OMON49316
Completed
Not Applicable
Image guided surgery for margin assessment of cutaneous squamous cell carcinoma during surgery: a phase I proof of concept study - Image guided skin cancer surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- skin cancer
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Biopsy confirmed diagnosis of cSCC and scheduled to undergo surgical
- •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
- •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;
Outcomes
Primary Outcomes
Not specified
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