The Diagnostic Accuracy of Advanced Imaging in Identifying Suspected Skin Cancer (Basal Cell Carcinoma) Around the Eyes
- Conditions
- Eyelid DiseasesBCCBCC - Basal Cell CarcinomaSkin DiseasesEyelid Tumor
- Registration Number
- NCT06279143
- Lead Sponsor
- Vejle Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 210
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic accuracy of D-OCT in diagnosing BCC inside the periocular region, compared to previous reports on lesions outside the periocular region 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 Outcome Measures
Name Time Method Quantification of skills in correctly demarcating BCC over time with increasing experience with D-OCT March 2024-August 2026 This measure, quantifies the improvement in skills over time among observers in precisely delineating the borders of BCC lesions prior to surgery using D-OCT imaging. It assesses the improvement in demarcation accuracy with increasing experience.
Accuracy of D-OCT in delineation of periocular BCC extension prior to surgery March 2024-August 2026 Evaluation af sensitivity of D-OCT imaging in delineation (mapping) of periocular BCC tumour extension - comparing findings with visible boundaries and histopathological diagnosis (considered the gold standard)
Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for subtyping BCC March 2024-August 2026 To compare the sensitivity and specificity of each D-OCT probe for subtyping periocular BCC, with reference to punch biopsy results.
Observer agreement in identifying presence/absence of BCC lesions, using D-OCT March 2024-August 2026 This measure, assesses the consistency among observers in identifying the presence or absence of BCC lesions through the utilization of D-OCT imaging.
Quantification of learning curve in correctly diagnosing BCC over time with increasing experience with D-OCT March 2024-August 2026 This measure, quantifies the improvement in skills over time among observers in diagnosing BCC lesions using D-OCT imaging. It aims to determine the rate at which observers become adept at interpreting D-OCT images for BCC diagnosis.
Observer agreement in mapping BCC lesions prior to surgery, using D-OCT March 2024-August 2026 This measure, examines the agreement among observers in accurately mapping the extension of BCC lesions prior to surgery with the assistance of D-OCT imaging.
Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for diagnosing BCC March 2024-August 2026 To compare the sensitivity and specificity of each D-OCT probe for diagnosing periocular BCC, with reference to punch biopsy results.
Observer agreement in classifying BCC lesions into subtypes, using D-OCT March 2024-August 2026 This measure, evaluates the level of agreement among observers in categorizing BCC lesions into specific subtypes based on D-OCT imaging. Potential diagnostic features from lesion types will be tested.
Quantification of learning curve in correctly identifying BCC subtypes over time with increasing experience with D-OCT March 2024-August 2026 This measure, quantifies the improvement in skills over time among observers in accurately identifying different subtypes of BCC lesions using D-OCT imaging. It aims to determine the rate at which observers become adept at interpreting D-OCT images for BCC subtyping.
Trial Locations
- Locations (1)
Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital
🇩🇰Vejle, Region Of Southern Danmark, Denmark