Clinical trial · Observational
The Diagnostic Accuracy of Advanced Imaging in Identifying Suspected Skin Cancer (Basal Cell Carcinoma) Around the Eyes
The Diagnostic Value of Dermal Optical Coherence Tomography (D-OCT) for Clinically Suspected Basal Cell Carcinoma Lesion (BCC) in the Periocular Area
- 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 purpose is to investigate the diagnostic value (sensitivity and specificity) of dermal-Optical Coherence Tomography (D-OCT, VivoSight Dx), in patients with clinically suspected BCC lesions inside the periocular region and compare these results to previous reports using D-OCT in diagnosing lesions outside the periocular area. The Hypotheses: * The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is comparable to previous reports on BCC lesions outside the periocular region when the standard D-OCT probe is used. * The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is increased when the customised D-OCT probe is used. * The sensitivity and specificity of D-OCT in diagnosing periocular BCC is comparable to punch biopsy when both standard and the customised D-OCT probes are used. * D-OCT with the 10 and 20-millimeter standoff is capable of subtyping periocular BCC. * The inter-observer variation in diagnosing and sub-typing periocular BCC decreases with increasing experience in the scanning procedure. * The number of scans to correctly interpret D-OCT decreases with increasing experience in the scanning procedure. * Delineation of periocular BCC tumour extension is possible using both D-OCT probes
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BCC | Skin Basal Cell Carcinoma | ALIAS | 0.90 |
| BCC - Basal Cell Carcinoma | — | UNRESOLVED | — |
| Eyelid Diseases | — | UNRESOLVED | — |
| Eyelid Tumor | Eyelid Neoplasm | ALIAS | 0.90 |
| Skin Diseases | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic accuracy of D-OCT in diagnosing BCC inside the periocular region, compared to previous reports on lesions outside the periocular region
- timeFrame
- March 2024-August 2026
- description
- To assess if the sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is comparable to previous reports on BCC lesions outside the periocular region using the standard probe
Secondary outcomes (9)
- measure
- Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for diagnosing BCC
- timeFrame
- March 2024-August 2026
- description
- To compare the sensitivity and specificity of each D-OCT probe for diagnosing periocular BCC, with reference to punch biopsy results.
- measure
- Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for subtyping BCC
- timeFrame
- March 2024-August 2026
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Clinically suspected periocular BCC. * Biopsy-verified BCC * Clinically suspected relapse of periocular BCC * Age more than 18 years at baseline. * Legally competent, able to give verbal and written consent * Communicate in Danish verbally as well as in writing * Willingness to participate and able to give informed consent and can comply with protocol requirements. Exclusion Criteria: * Anatomical circumstances that make OCT-scanning impossible, i.e., extensive scarring of eyelids, or large ulcerating crusts that hampers scanning * Unwillingness to undergo a skin biopsy or excision of lesion. * Inability to sign informed consent.
References
Publications (0)
Data not yet available