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Clinical Trial 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


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06279143
Study type Observational
Source Vejle Hospital
Contact Sveina B Karlsdóttir, Ph.D.Student
Phone 53 42 04 48
Email sveina.bjork.karlsdottir@rsyd.dk
Status Recruiting
Phase
Start date April 4, 2024
Completion date November 30, 2026

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