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AI-aided Optical Coherence Tomography for the Detection of Basal Cell Carcinoma

NCT05817279 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 124

Last updated 2024-02-16

No results posted yet for this study

Summary

Basal cell carcinoma (BCC) is the most common form of cancer among the Caucasian population. A BCC diagnosis is commonly establish by means of an invasive punch biopsy (golden standard). Optical coherence tomography (OCT) is a safe non-invasive diagnostic modality which may replace biopsy if an OCT assessor is able to establish a high confidence BCC diagnosis. Hence, for clinical implementation of OCT, diagnostic certainty should be as high as possible. Artificial intelligence in the form of a clinical decision support system (CDSS) may improve the diagnostic certainty of newly trained OCT assessors by highlighting suspicious areas on OCT scans and by providing diagnostic suggestions (classification). This study will evaluate the effect of a CDSS on the diagnostic certainty and accuracy of OCT assessors.

Conditions

Interventions

DIAGNOSTIC_TEST

Optical coherence tomography

Optical coherence tomography: OCT is a non-invasive CE-certified diagnostic modality based on light interferometry. An OCT scan visualizes an area with a diameter of 6mm thereby revealing the skin and adnexal structures with a depth of approximately 1.5mm. 3mm punch biopsy: the patients included in this study underwent a 3mm punch biopsy conform regular care. The subsequent histopathological examination of the biopsy specimen serves as ground truth diagnosis of the lesions (gold standard)

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-10
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05817279 on ClinicalTrials.gov