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Recruiting NCT06279143

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

Trial Parameters

Condition BCC - Basal Cell Carcinoma
Sponsor Vejle Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 210
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-04-04
Completion 2026-08-31

Brief 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

Eligibility Criteria

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.

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