D-OCT for Detection and Subtyping of BCC: a Diagnostic Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner.
- Who it may be relevant to
- Registry conditions: Basal Cell Carcinoma, Optical Coherence Tomography. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dynamic Optical Coherence Tomography for Detection and Subtyping of Basal Cell
Overview
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.
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).
Primary outcome measures
- Diagnostic accuracy for BCC detection on D-OCT assessment [Time frame: Measured before December 31st 2024]
Secondary outcome measures (2)
- Diagnostic accuracy for BCC subtyping on D-OCT assessment [Time frame: Measured before December 31st 2024]
- Diagnostic value of vascular structures and patterns [Time frame: Measured before December 31st 2024]
Eligibility criteria
Inclusion criteria
- 18+ years
- Lesions suspect for non-melanoma skin cancer or premalignancy
- Patient underwent D-OCT scan and biopsy conform regular care
Exclusion criteria
- Patient unable to sign informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06273722 · 2024-0059