RecruitingNCT06279143

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


Sponsor

Vejle Hospital

Enrollment

210 participants

Start Date

Apr 4, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether advanced imaging techniques — specifically OCT (optical coherence tomography) scanning — can more accurately detect and map basal cell carcinoma (BCC, a common type of skin cancer) around the eye area, potentially reducing the need for multiple surgeries or biopsies. **You may be eligible if...** - You have a suspected or confirmed basal cell carcinoma near or around your eyes - You are over 18 years old - You are able to give written informed consent - You can communicate in Danish **You may NOT be eligible if...** - Extensive scarring of your eyelids or large skin crusts prevent scanning - You are unwilling to have a skin biopsy or surgical removal of the lesion - You are unable to sign informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

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

Vejle, Region of Southern Danmark, Denmark

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NCT06279143


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