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

NCT ID: NCT05817279

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 124 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-10
• Study Completion Date: 2024-12-31

Brief 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.

Detailed Description

In this diagnostic case control design, OCT assessors will retrospectively evaluate OCT scans of equivocal BCC lesions twice (once with, and once without the help of the CDSS). A total of 124 scans (62 BCC/62 non-BCC) will be included in the study. Cases will be shuffled to prevent recall bias. AI-aided OCT scans and unaided OCT scans will be presented in alternating order. The assessors will express their certainty level on a 5-point confidence scale. The diagnostic certainty and diagnostic accuracy of OCT assessment with CDSS and without CDSS will be compared.

Research questions:

1. Does AI-aided OCT assessment result in an increase in high-confidence diagnoses compared to unaided OCT assessment?

2. Does AI-aided OCT assessment result in a significant increase in sensitivity for BCC detection without compromising specificity compared to unaided OCT assessment?

3. Does AI-aided OCT assessment result in more accurate BCC subtyping compared to unaided OCT assessment (explorative)

Conditions

Basal Cell Carcinoma; Optical Coherence Tomography

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

AI-OCT

Group of 124 patients with equivocal BCC lesions. Of these lesions, OCT scans have been obtained in the past. These scans will be evaluated with AI-assistance.

Optical coherence tomography

Intervention Type: DIAGNOSTIC_TEST

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)

Unaided OCT

Group of 124 patients with equivocal BCC lesions (same patients as in AI-OCT group). Of these lesions, OCT scans have been obtained in the past. These scans will be evaluated without AI-assistance.

Optical coherence tomography

Intervention Type: DIAGNOSTIC_TEST

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)

Interventions

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)

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

3mm punch biopsy

Eligibility Criteria

Inclusion Criteria

• Patients (18+ years)
• Patient underwent OCT scan and punch biopsy for an equivocal BCC lesion

Exclusion Criteria

• Patient unable to sign informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maastricht University Medical Center+

Maastricht, Limbrug, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Facility Contacts

Tom Wolswijk, MD, MSc

Role: primary

tom.wolswijk@mumc.nl

+31(0)42-3877295

Other Identifiers

2022-3517

Identifier Type: -

Identifier Source: org_study_id