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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:
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of D-OCT in diagnosing BCC inside the periocular region, compared to previous reports on lesions outside the periocular region | 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 | March 2024-August 2026 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for diagnosing BCC | To compare the sensitivity and specificity of each D-OCT probe for diagnosing periocular BCC, with reference to punch biopsy results. | March 2024-August 2026 |
| Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for subtyping BCC |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive enrolment of newly referred patients under the diagnosis "clinically suspected BCC" in the periocular area
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| Name | Affiliation | Role |
|---|---|---|
| Flemming Møller, Assoc.prof. | Vejle Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital | Vejle | Region of Southern Danmark | 7100 | Denmark |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| D012871 | Skin Diseases |
| D005142 | Eyelid Neoplasms |
| D005141 | Eyelid Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D012878 | Skin Neoplasms |
| D006967 | Hypersensitivity |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018295 | Neoplasms, Basal Cell |
| D017437 | Skin and Connective Tissue Diseases |
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To compare the sensitivity and specificity of each D-OCT probe for subtyping periocular BCC, with reference to punch biopsy results. |
| March 2024-August 2026 |
| Observer agreement in identifying presence/absence of BCC lesions, using D-OCT | This measure, assesses the consistency among observers in identifying the presence or absence of BCC lesions through the utilization of D-OCT imaging. | March 2024-August 2026 |
| Observer agreement in classifying BCC lesions into subtypes, using D-OCT | 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. | March 2024-August 2026 |
| Observer agreement in mapping BCC lesions prior to surgery, using D-OCT | 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. | March 2024-August 2026 |
| Quantification of learning curve in correctly diagnosing BCC over time with increasing experience with D-OCT | 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. | March 2024-August 2026 |
| Quantification of learning curve in correctly identifying BCC subtypes over time with increasing experience with D-OCT | 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. | March 2024-August 2026 |
| Quantification of skills in correctly demarcating BCC over time with increasing experience with D-OCT | 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. | March 2024-August 2026 |
| Accuracy of D-OCT in delineation of periocular BCC extension prior to surgery | 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) | March 2024-August 2026 |
| D005153 | Facial Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D005134 | Eye Neoplasms |
| D005128 | Eye Diseases |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |