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

April 30, 2026 updated by: David M. Ozog, Henry Ford Health System

Artificial Intelligence Enhanced Optical Coherence Tomography (AI-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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Validation of AI-OCT as an accurate method for detecting basal cell carcinomas
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18605

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Basal Cell Carcinoma of Skin

Clinical Trials on AI-OCT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe