Not Yet RecruitingNot Applicable

AI-enhanced OCT Imaging for Pre-surgical Margin Detection of Basal Cell Carcinoma

30 participantsStarted 2026-09

Plain-language summary

Basal cell carcinomas (BCCs) are the most common human malignancy, affecting about 2 million Americans each year. Mohs micrographic surgery (MMS) removes tissue by sequential excision. Costs for MMS could be reduced if the number of necessary excision stages were decreased by a more accurate initial tumor margin assessment. The goal of this observational study is to learn if Optical Coherence Tomography (OCT) used in conjunction with artificial intelligence algorithms is accurate in the detection of superficial BCC margins prior to MMS. This study also aims to determine if AI-OCT guided margin delineation can reduce the number of stages in MMS. Researchers will first focus on validating AI-OCT as a method for accurately detecting BCCs. A follow-up study would then address the guided pre-surgical margin delineation.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or Female, ages 18 or older * at least one biopsy proven superficial or nodular BCC * willingness to have photographs taken of the treatment area * ability to understand and willingness to sign a written informed consent document Exclusion Criteria: * infiltrative, micronodular, or morpheaform BCC * pregnant women * subjects not willing to have a biopsy taken from the treatment area * subjects with herpes simplex virus infection in the treatment area

What they're measuring

Validation of AI-OCT as an accurate method for detecting basal cell carcinomas

Timeframe: 2 years

Trial details

NCT IDNCT07358637

SponsorHenry Ford Health System

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12

View on ClinicalTrials.gov More Basal Cell Carcinoma of Skin trials