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D-OCT for Detection and Subtyping of BCC: a Diagnostic Cohort Study
Sponsor: Maastricht University Medical Center
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.
Official title: Dynamic Optical Coherence Tomography for Detection and Subtyping of Basal Cell
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
424
Start Date
2024-11-01
Completion Date
2025-08-01
Last Updated
2024-10-26
Healthy Volunteers
No
Interventions
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).