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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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.

Study details
    BCC - Basal Cell Carcinoma
    BCC
    Skin Diseases
    Eyelid Tumor
    Eyelid Diseases

NCT06279143

Vejle Hospital

25 May 2025

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