NCT05817279

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

April 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

1.7 years

First QC Date

April 4, 2023

Last Update Submit

February 15, 2024

Conditions

Basal Cell CarcinomaOptical Coherence Tomography

Keywords

Basal cell carcinomaBCCOptical coherence tomographyOCTImagingArtificial intelligenceMachine learning

Outcome Measures

Primary Outcomes (1)

  • Proportion of high-confidence diagnoses

    The difference in percentage of high-confidence diagnoses will be evaluated between AI-OCT and unaided OCT.

    31-12-2023

Secondary Outcomes (2)

  • Diagnostic accuracy of high-confidence diagnoses

    31-12-2023

  • Diagnostic parameters for BCC subtyping

    31-12-2023

Study Arms (2)

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.

Diagnostic Test: Optical coherence tomography

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.

Diagnostic Test: Optical coherence tomography

Interventions

Optical coherence tomographyDIAGNOSTIC_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)

Also known as: 3mm punch biopsy
AI-OCTUnaided OCT

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Scans of patients with equivocal BCC lesions will be included. Patients previously underwent an OCT scan and punch biopsy for their lesion. Patients signed informed consent for the use of the OCT scans made and patient information for the sake of answering research questions regarding OCT.

You may qualify if:

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

You may not qualify if:

  • \- Patient unable to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Limbrug, 6202AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2023

First Posted

April 18, 2023

Study Start

April 10, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

NL(1)