Clinical trial · Observational
cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma: a Diagnostic Cohort Study
- 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)
Basal cell carcinoma (BCC) is the most common form of cancer among the Caucasian population. Equivocal BCC lesions are usually diagnosed by means of a punch biopsy, but since the last few decades, non-invasive imaging techniques for the diagnosis of BCC gained popularity within the field of dermatology. Conventional optical coherence tomography (cOCT) is an example of a non-invasive imaging technique. Recent studies revealed that OCT assessors may achieve high diagnostic certainty and accuracy for diagnosing BCC. However, cOCT has a limited axial and lateral resolution and can therefore only visualize the gross architecture of the skin. It has been proposed that the diagnostic certainty and accuracy of cOCT could be optimized by improving the resolution. Line-field confocal optical coherence tomography (LC-OCT) is a new non-invasive imaging technique that provides tridimensional images of the skin with a cellular resolution. Although the resolution of LC-OCT is superior to cOCT, the penetration depth of LC-OCT (500µm) is limited compared to that of cOCT (1.0-1.5mm). In the proposed study, we aim to assess whether LC-OCT is superior to cOCT in terms of diagnostic accuracy for diagnosing BCC in equivocal BCC lesions.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cOCT and LC-OCT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with equivocal BCC lesions
- description
- Patients with equivocal BCC lesions (18+ years) who will undergo biopsy conform regular care will undergo a cOCT and LC-OCT scan.
- interventionNames
- Device: cOCT and LC-OCT
Primary outcomes (1)
- measure
- Diagnostic accuracy of cOCT and LC-OCT
- timeFrame
- Measured before september 1st 2024
- description
- Diagnostic parameters such as sensitivity, specificity, PPV, NPV and DOR will be evaluated for diagnosing BCC in patients with equivocal lesions and compared between both imaging devices.
Secondary outcomes (1)
- measure
- Diagnostic accuracy for BCC subtyping on cOCT and LC-OCT
- timeFrame
- Measured before september 1st 2024
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients (18+) with equivocal BCC lesions undergoing biopsy conform regular care Exclusion Criteria: * Patients unable to sign informed consent * Patients with clinically evident BCC lesions who do not undergo biopsy
References
Publications (0)
Data not yet available