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RECRUITING
NCT06279143

The Diagnostic Accuracy of Advanced Imaging in Identifying Suspected Skin Cancer (Basal Cell Carcinoma) Around the Eyes

Sponsor: Vejle Hospital

View on ClinicalTrials.gov

Summary

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

Official title: The Diagnostic Value of Dermal Optical Coherence Tomography (D-OCT) for Clinically Suspected Basal Cell Carcinoma Lesion (BCC) in the Periocular Area

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

210

Start Date

2024-04-04

Completion Date

2027-04-20

Last Updated

2025-05-20

Healthy Volunteers

No

Locations (1)

Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital

Vejle, Region of Southern Danmark, Denmark