NCT06273709

Remote Assessment of OCT Scans for BCC Detection

The Value of Visual Inspection When Remotely Diagnosing Basal Cell Carcinoma on Optical Coherence Tomography Scans: a Diagnostic Case-control Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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).

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
DEVICE	Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner	(Michelson Diagnostics Maidstone, Kent, UK; resolution \<7.5 µm lateral, \<5 µm axial; depth of focus 1.0 mm; scan area 6 × 6 mm).

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-07-01
• Completion: 2024-12-31
• First posted: 2024-02-22
• Last updated: 2024-02-22