An observational study in BCC - Basal Cell Carcinoma, BCC and Skin Diseases, sponsored by Vejle Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Vejle Hospital · Observational
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:
Consecutive enrolment of newly referred patients under the diagnosis "clinically suspected BCC" in the periocular area
Exclusion Criteria:
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
Time frame: March 2024-August 2026
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.
Time frame: March 2024-August 2026
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: March 2024-August 2026
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Vejle Hospital