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

NCT07358637 | Not Yet Recruiting

• 1 other identifier: 18605
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Basal Cell Carcinoma of Skin

Outcome Measures

Primary Outcomes (1)

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

  2 years

Interventions

AI-OCT DIAGNOSTIC_TEST

Optical Coherence Tomography augmented by artificial intelligence software

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with biopsy-confirmed BCC who are scheduled to receive Mohs micrographic surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04