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

NCT06279143 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 210

Last updated 2025-05-20

No results posted yet for this study

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

Conditions

  • BCC - Basal Cell Carcinoma
  • BCC
  • Skin Diseases
  • Eyelid Tumor
  • Eyelid Diseases

Sponsors & Collaborators

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Flemming Møller, Assoc.prof. · Vejle Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-04
Primary Completion
2026-08-31
Completion
2027-04-20

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06279143 on ClinicalTrials.gov