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

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

NCT ID: NCT06273722

Condition: Basal Cell Carcinoma
Optical Coherence Tomography

Conditions: Official terms:
Carcinoma, Basal Cell

Conditions: Keywords:
Basal cell carcinoma
Optical coherence tomography
Imaging
Non-melanoma skin cancer

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Retrospective

Intervention:

Intervention type: Device
Intervention name: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner
Description: 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).
Arm group label: D-OCT scanned patients

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.

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: November 1, 2024

Completion date: August 1, 2025

Lead sponsor:
Agency: Maastricht University Medical Center
Agency class: Other

Source: Maastricht University Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06273722