AI-enhanced OCT Imaging for Pre-surgical Margin Detection of Basal Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-OCT.
- Who it may be relevant to
- Registry conditions: Basal Cell Carcinoma of Skin. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Artificial Intelligence Enhanced Optical Coherence Tomography (AI-OCT) Imaging for Pre-surgical Margin Detection of Basal Cell Carcinoma
Overview
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 test AI-OCT
Optical Coherence Tomography augmented by artificial intelligence software
Primary outcome measures
- Validation of AI-OCT as an accurate method for detecting basal cell carcinomas [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07358637 · 18605