Remote Assessment of OCT Scans for BCC Detection

Not yet recruiting

• Conditions: Basal Cell Carcinoma
• Interventions: Device: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner

• Registration Number: NCT06273709
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

Basal cell carcinoma (BCC) is the most common form of cancer and entails approximately 80% of all cutaneous malignancies. This locally destructive neoplasm is commonly diagnosed by punch biopsy which is considered painful, causes procedural scarring and carries a small risk of infection and re-bleeding associated with invasive procedures. Moreover, awaiting the results of the subsequent histopathological examination causes treatment delay and can be stressful for the patient. The drawbacks of biopsy could be overcome by optical coherence tomography (OCT), a non-invasive diagnostic modality that may replace biopsy in up to 66% of patients. However, OCT assessors are scarce which hinders the implementation of OCT. This problem may be addressed by teledermatology in which remote OCT assessment by an assessor facilitates simultaneous assessment for multiple clinics. Remote OCT assessment withholds the OCT assessor from visually inspecting the lesion. But the effect of visual inspection on the diagnostic accuracy remains unknown and the question arises whether visual inspection is necessary for accurate OCT assessment. In this diagnostic case-control study we will determine whether distant OCT assessment without visual information on the lesion is non-inferior to distant OCT assessment with clinical and dermoscopic photographs (CDP-OCT).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-15
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Study First Posted: 2024-02-22
• Last Update Posted: 2024-02-22
• Study Start: 2024-03-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 18+ years of age
• Underwent OCT scan and punch biopsy for lesions suspect for BCC

Exclusion Criteria

• Unable to sign informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OCT scans with clinical/dermoscopic photographs	Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner	The same OCT scans will be used . OCT assessment is performed in conjunction with clinical and dermoscopic photographs.
OCT scans without clinical/dermoscopic photographs	Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner	OCT scans will be used from a pre-existing registry. The OCT scans are made of lesions clinically suspect for BCC. All patients underwent punch biopsy conform regular care.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of high-confidence BCC diagnosis with and without clinical/dermoscopic photographs	Measured before December 31st 2024	Diagnostic accuracy of a high confidence diagnosis (confidence-score 4) will be expressed by diagnostic parameters, such as sensitivity, specificity, positive predictive value (PPV), negative predicitive value (NPV), and diagnostic odds ratios (DOR) with 95% confidence intervals. The primary outcome in this study is specificity of a high confidence diagnosis, defined as the proportion of histological non-BCC lesions that are classified as non-BCC on OCT.