BCC, BCC - Basal Cell Carcinoma, Eyelid Diseases, Eyelid Tumor, Skin Diseases
Conditions
Keywords
Carcinoma, Basal Cell* / diagnostic imaging, Carcinoma, Basal Cell* / pathology, Carcinoma, Basal Cell* / surgery, Neoplasm, Glandular and epithelial, Skin neoplasm, Diagnostic imaging, Sensitivity and Specificity, Tomography, Optical Coherence* / methods, Skin Neoplasm* / surgery, Neoplasm recurrence, Eyelids / pathology, Skin diseases, Periocular, BCC
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
Interventions
None listed
Sponsors
Vejle Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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) |
Countries
Denmark
Contacts
STUDY_DIRECTORFlemming Møller, Assoc.prof.
Vejle Hospital
Outcome results
None listed