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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHenry Ford Health System

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • AI-OCT

    Diagnostic test

    Optical Coherence Tomography augmented by artificial intelligence software

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
2 years

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: