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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07358637
Enrollment
30
Registered
2026-01-22
Start date
2026-09-01
Completion date
2028-12-01
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal Cell Carcinoma of Skin

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.

Interventions

DIAGNOSTIC_TESTAI-OCT

Optical Coherence Tomography augmented by artificial intelligence software

Sponsors

Henry Ford Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Validation of AI-OCT as an accurate method for detecting basal cell carcinomas2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026