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Not Yet RecruitingNCT07358637

Artificial Intelligence Enhanced Optical Coherence Tomography (AI-OCT) Imaging for Pre-surgical Margin Detection of Basal Cell Carcinoma

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
30 (estimated)
Sponsor
Henry Ford Health System · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTAI-OCTOptical Coherence Tomography augmented by artificial intelligence software

Timeline

Start date
2026-03-01
Primary completion
2027-12-01
Completion
2028-12-01
First posted
2026-01-22
Last updated
2026-01-22

Source: ClinicalTrials.gov record NCT07358637. Inclusion in this directory is not an endorsement.