Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06273722

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

Sponsor: Maastricht University Medical Center

View on ClinicalTrials.gov

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

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).