Skin Diseases Clinical Trial
— dOCT-pBCCOfficial title:
The Diagnostic Value of Dermal Optical Coherence Tomography (D-OCT) for Clinically Suspected Basal Cell Carcinoma Lesion (BCC) in the Periocular Area
NCT number | NCT06279143 |
Other study ID # | dOCT-pBCC |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 4, 2024 |
Est. completion date | November 30, 2026 |
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
Status | Recruiting |
Enrollment | 210 |
Est. completion date | November 30, 2026 |
Est. primary completion date | August 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital | Vejle | Region Of Southern Danmark |
Lead Sponsor | Collaborator |
---|---|
Vejle Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for subtyping BCC | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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