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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMaastricht University Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

18+ years

Lesions suspect for non-melanoma skin cancer or premalignancy

Patient underwent D-OCT scan and biopsy conform regular care

Disqualifiers

Patient unable to sign informed consent.

Trial design

Treatments tested in this trial

  • Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner

Treatment groups

424 Participants
are divided into 1 treatment group

Locations

This trial has no locations