NCT06273722

D-OCT for Detection and Subtyping of BCC: a Diagnostic Cohort Study

Dynamic Optical Coherence Tomography for Detection and Subtyping of Basal Cell

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 424 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The current gold standard for diagnosing basal cell carcinoma (BCC) is the histopathological examination of biopsy specimen. However, non-invasive imaging modalities such as optical coherence tomography (OCT) may replace biopsy if BCC presence and its subtype can be established with high confidence. Subtype differentiation is crucial; while superficial BCCs (sBCC) can be treated topically, nodular (nBCC) and infiltrative BCCs (iBCC) require excision. Dynamic OCT (D-OCT) is a functionality integrated within the OCT device, enabling the visualization of vascular structures through speckle variance. Descriptive studies have unveiled vascular shapes and patterns associated with BCC and its respective subtypes. These findings suggest that D-OCT could contribute to the accuracy of BCC detection and subtyping. Yet comparative clinical studies between OCT and D-OCT are lacking. In the proposed diagnostic cohort study, we aim to assess whether D-OCT assessment is superior to OCT in terms of accuracy for BCC detection and subtyping.

Conditions

• Basal Cell Carcinoma
• Optical Coherence Tomography

Interventions

Type	Name	Description
DEVICE	Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner	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: 2024-11-01
• Primary completion: 2025-07-01
• Completion: 2025-08-01
• First posted: 2024-02-22
• Last updated: 2024-10-26