Pilot Study of LC-OCT for Basal Cell Carcinoma Margins

This study is testing a new handheld imaging device called Line-Field Confocal Optical Coherence Tomography (LC-OCT Imaging) to see how well it can help doctors check the edges of basal cell carcinomas (a common type of skin cancer) before Mohs micrographic surgery. Doctors want to see if this device can provide useful information for planning surgery. You may be able to join if you are 18 or older, understand the study, and are already scheduled for Mohs surgery for basal cell carcinoma. The main goal is to see how many cases result in clear, usable images from the device. The current status of this study is unclear, and it plans to enroll 60 participants.

Study design
This is an interventional study designed to enroll 60 participants. It is a pilot study, meaning it's an early look at the usefulness of the LC-OCT device.
What's involved
Participants will have high-resolution images taken of their lesion using the handheld LC-OCT Imaging device. The study aims to measure the number of cases with evaluable images over 1.5 years.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, which assesses the number of cases with fully evaluable images, is measured at 1.5 years.

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NCT07182240

Pilot Study of Line-Field Confocal Optical Coherence Tomography for Detection of Mohs Micrographic Surgery Margins of Basal Cell Carcinomas

Recruiting
NAAges 18+InterventionalDiagnostic
Roswell Park Cancer Institute
~60 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:LC-OCT Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of cases with fully evaluable images
Measured over 1.5 years
Basal Cell Carcinoma
1 sites across 1 states
New York1
  • Gyorgy Paragh, MD · PRINCIPAL_INVESTIGATOR · Roswell Park

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Eligibility criteria

Inclusion

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.

Exclusion

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
  • Number of cases with fully evaluable images1.5 years

    cases were the image evaluator can assess the margins based on image quality