Clinical trial · Observational
Optical-Coherence Tomography for the Non-invasive Diagnosis and Subtyping of Basal Cell Carcinoma
- 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)
Rationale: To date, the diagnosis and subtyping of basal cell carcinoma (BCC) is verified with histopathology which requires a biopsy. Because this technique is invasive, new non-invasive strategies have been developed, including Optical Coherence Tomography (OCT). This innovative technique enables microscopically detailed examination of lesions, which is useful for diagnosing and identification of various subtypes of BCC. The diagnostic value of the VIVOSIGHT OCT in daily clinical practice, has not been established to date.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Artificial Intelligence | — | UNRESOLVED | — |
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Deep Learning | — | UNRESOLVED | — |
| Optical Coherence Tomography | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Optical Coherence Tomography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Prospective data collection, retrospective OCT image evaluation
- description
- From February 2017-June 2017 patients were included prospectively. OCT images were evaluated retrospectively in conjunction with clinical images. A deep learning algorithm is developed with use of this dataset including 676 OCT images.
- interventionNames
- Device: Optical Coherence Tomography
- label
- Prospective data collection and OCT image evaluation
- description
- From January 2021-April 2021 patients were included prospectively. OCT images were evaluated prospectively in a clinical setting. The deep learning algorithm will be prospectively validated with use of this dataset including 287 OCT images.
- interventionNames
- Device: Optical Coherence Tomography
Primary outcomes (1)
- measure
- Diagnostic accuracy of OCT in diagnosis and subtyping of BCC
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (18 years or older) receiving a skin biopsy of a lesion clinically suspected for a non-melanoma skin cancer or premalignancy Exclusion Criteria: * Patients who were incompetent to sign informed consent were excluded
References
Publications (1)
- RESULTSinx KAE, van Loo E, Tonk EHJ, Kelleners-Smeets NWJ, Winnepenninckx VJL, Nelemans PJ, Mosterd K. Optical Coherence Tomography for Noninvasive Diagnosis and Subtyping of Basal Cell Carcinoma: A Prospective Cohort Study. J Invest Dermatol. 2020 Oct;140(10):1962-1967. doi: 10.1016/j.jid.2020.01.034. Epub 2020 Mar 6. PMID 32147505