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Clinical Trials/NCT06279143
NCT06279143CompletedNot Applicable

The Diagnostic Value of Dermal Optical Coherence Tomography (D-OCT) for Clinically Suspected Basal Cell Carcinoma Lesion (BCC) in the Periocular Area

Vejle Hospital2 sites in 1 country210 target enrollmentStarted: April 4, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
210
Locations
2
Primary Endpoint
Diagnostic accuracy of D-OCT in diagnosing BCC inside the periocular region, compared to previous reports on lesions outside the periocular region
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Diagnostic accuracy of D-OCT in diagnosing BCC inside the periocular region, compared to previous reports on lesions outside the periocular region

Time Frame: March 2024-August 2026

To assess if 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 using the standard probe

Secondary Outcomes

  • Quantification of skills in correctly demarcating BCC over time with increasing experience with D-OCT(March 2024-August 2026)
  • Accuracy of D-OCT in delineation of periocular BCC extension prior to surgery(March 2024-August 2026)
  • Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for subtyping BCC(March 2024-August 2026)
  • Observer agreement in identifying presence/absence of BCC lesions, using D-OCT(March 2024-August 2026)
  • Quantification of learning curve in correctly diagnosing BCC over time with increasing experience with D-OCT(March 2024-August 2026)
  • Observer agreement in mapping BCC lesions prior to surgery, using D-OCT(March 2024-August 2026)
  • Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for diagnosing BCC(March 2024-August 2026)
  • Observer agreement in classifying BCC lesions into subtypes, using D-OCT(March 2024-August 2026)
  • Quantification of learning curve in correctly identifying BCC subtypes over time with increasing experience with D-OCT(March 2024-August 2026)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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