Clinical trial · Observational
D-OCT for Detection and Subtyping of BCC: a Diagnostic Cohort Study
Dynamic Optical Coherence Tomography for Detection and Subtyping of Basal Cell
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Optical Coherence Tomography | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Device: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner
Primary outcomes (1)
- measure
- Diagnostic accuracy for BCC detection on D-OCT assessment
- timeFrame
- Measured before December 31st 2024
- description
- We will evaluate the ability of OCT assessors to discriminate BCC from non-BCC using OCT without and with dynamic functionality. The diagnostic certainty for BCC detection will be expressed on a five-point confidence scale. A high confidence score (confidence score=4) is considered a positive OCT test results. In these cases, biopsy could effectively be omitted. Lower confidence scores (confidence score≤3) are considered negative OCT test results as in these cases, biopsy remains necessary for a definitive or alternative diagnosis. The primary outcome of interest is the sensitivity of a high confidence BCC diagnosis because we want to evaluate whether the dynamic functionality increases the proportion of correctly classified BCCs.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available