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NCT Number: NCT07358637

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

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.

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Key information

Conditions

Basal Cell Carcinoma of Skin Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI-OCT

Diagnostic Test

Optical Coherence Tomography augmented by artificial intelligence software

Primary outcomes

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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 22, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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