About this trial
To assess the feasibility and provide information on the utility of noninvasive line field confocal optical coherence tomography (LC-OCT) for the presurgical assessment of Mohs micrographic surgery sites in patients undergoing removal of cutaneous basal cell carcinomas (BCC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Participant must understand the investigational nature of this study and provide written consent prior to receiving any study-related procedure.
Participant must be clinically eligible for Mohs surgery as determined by their referring dermatologist and the Mohs surgeon.
The participant must have a BCC with superficial histology or a BCC with multiple histological features that also include superficial histology, which is appropriate for Mohs surgery.
Disqualifiers
Known or reported allergy to mineral oil, the optical agent used during imaging.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
. Any condition which in the investigator's opinion deems the subject an unsuitable candidate to undergo imaging procedure.
Unwilling or unable to follow protocol requirements
Trial design
Single group
Treatments tested in this trial
LC-OCT Imaging
Devicehandheld imaging device will take high resolution images of lesion
Treatment groups
Trial outcomes
Primary outcomes
Number of cases with fully evaluable images
cases were the image evaluator can assess the margins based on image quality
Secondary outcomes
Patient interest in study
Will be measured by documenting the number of patients offered study participation and the number choosing to participate in the study
Patients overall experience
Collect a 3-question questionnaire to document patients experience.
Determine LC-OCT imaging's impact on surgical workflow
Will be assessed by results of imaging assessment questionnaire given to surgeon
Accuracy of LC-OCT findings
Will be evaluated by Comparing LC-OCT findings with frozen section histopathological results
Sponsors and contacts
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