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

Maastricht University Medical Centre (MUMC)

Status: Not yet enrolling

Conditions: Optical Coherence Tomography; Basal Cell Carcinoma

Treatments: Device: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner

Study type: Observational

Funder types: Other

Identifiers

NCT06273722

2024-0059

Details and patient eligibility

About

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.

Enrollment: 424 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

424 participants in 1 patient group

D-OCT scanned patients

Description:

This diagnostic cohort study will include patients (18+ years) who underwent a biopsy and D-OCT scan for lesions suspect for BCC skin cancer. Patient data was retrieved from a pre-existing registry (METC: 2022-3555). All D-OCT scans were obtained at the outpatient dermatology clinic of Maastricht University Medical Center+ (MUMC+) using a 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). All scanned lesions were histopathologically examined by a dermatopathologist blinded to D-OCT scans and D-OCT assessment.

Treatment:

Device: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner