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

RECRUITINGSponsored by Vejle Hospital
Actively Recruiting
SponsorVejle Hospital
Started2024-04-04
Est. completion2026-08-31
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions6

BCCBCC - Basal Cell CarcinomaCancerEyelid DiseasesEyelid TumorSkin Diseases

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