Clinical trial · Observational
Remote Assessment of OCT Scans for BCC Detection
The Value of Visual Inspection When Remotely Diagnosing Basal Cell Carcinoma on Optical Coherence Tomography Scans: a Diagnostic Case-control 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 and entails approximately 80% of all cutaneous malignancies. This locally destructive neoplasm is commonly diagnosed by punch biopsy which is considered painful, causes procedural scarring and carries a small risk of infection and re-bleeding associated with invasive procedures. Moreover, awaiting the results of the subsequent histopathological examination causes treatment delay and can be stressful for the patient. The drawbacks of biopsy could be overcome by optical coherence tomography (OCT), a non-invasive diagnostic modality that may replace biopsy in up to 66% of patients. However, OCT assessors are scarce which hinders the implementation of OCT. This problem may be addressed by teledermatology in which remote OCT assessment by an assessor facilitates simultaneous assessment for multiple clinics. Remote OCT assessment withholds the OCT assessor from visually inspecting the lesion. But the effect of visual inspection on the diagnostic accuracy remains unknown and the question arises whether visual inspection is necessary for accurate OCT assessment. In this diagnostic case-control study we will determine whether distant OCT assessment without visual information on the lesion is non-inferior to distant OCT assessment with clinical and dermoscopic photographs (CDP-OCT).
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 |
|---|---|---|---|
| Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- OCT scans without clinical/dermoscopic photographs
- description
- OCT scans will be used from a pre-existing registry. The OCT scans are made of lesions clinically suspect for BCC. All patients underwent punch biopsy conform regular care.
- interventionNames
- Device: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner
- label
- OCT scans with clinical/dermoscopic photographs
- description
- The same OCT scans will be used . OCT assessment is performed in conjunction with clinical and dermoscopic photographs.
- interventionNames
- Device: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner
Primary outcomes (1)
- measure
- Diagnostic accuracy of high-confidence BCC diagnosis with and without clinical/dermoscopic photographs
- timeFrame
- Measured before December 31st 2024
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18+ years of age * Underwent OCT scan and punch biopsy for lesions suspect for BCC Exclusion Criteria: * Unable to sign informed consent
References
Publications (1)
- DERIVEDWolswijk T, Nelemans PJ, van Leersum F, Cruts E, Gerarda Moermans MM, Vreven L, Hillen LM, Mosterd K. The Impact of Clinical and Dermoscopic Photographs on the Diagnostic Accuracy of Remote Optical Coherence Tomography Assessment for Basal Cell Carcinoma Detection: A Comparative Diagnostic Study. Int J Dermatol. 2026 Jun;65(6):1231-1237. doi: 10.1111/ijd.70189. Epub 2025 Dec 10. PMID 41373084