protocolSection identificationModule nctId: NCT06279143, orgStudyIdInfo id: dOCT-pBCC, briefTitle: The Diagnostic Accuracy of Advanced Imaging in Identifying Suspected Skin Cancer (Basal Cell Carcinoma) Around the Eyes, acronym: dOCT-pBCC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2026-08-31, completionDateStruct date: 2026-11-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Vejle Hospital, class: OTHER, descriptionModule briefSummary: 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, conditionsModule conditions: BCC - Basal Cell Carcinoma, conditions: BCC, conditions: Skin Diseases, conditions: Eyelid Tumor, conditions: Eyelid Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 210, type: ESTIMATED, outcomesModule primaryOutcomes measure: Diagnostic accuracy of D-OCT in diagnosing BCC inside the periocular region, compared to previous reports on lesions outside the periocular region, secondaryOutcomes measure: Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for diagnosing BCC, secondaryOutcomes measure: Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for subtyping BCC, secondaryOutcomes measure: Observer agreement in identifying presence/absence of BCC lesions, using D-OCT, secondaryOutcomes measure: Observer agreement in classifying BCC lesions into subtypes, using D-OCT, secondaryOutcomes measure: Observer agreement in mapping BCC lesions prior to surgery, using D-OCT, secondaryOutcomes measure: Quantification of learning curve in correctly diagnosing BCC over time with increasing experience with D-OCT, secondaryOutcomes measure: Quantification of learning curve in correctly identifying BCC subtypes over time with increasing experience with D-OCT, secondaryOutcomes measure: Quantification of skills in correctly demarcating BCC over time with increasing experience with D-OCT, secondaryOutcomes measure: Accuracy of D-OCT in delineation of periocular BCC extension prior to surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital, status: RECRUITING, city: Vejle, state: Region Of Southern Danmark, zip: 7100, country: Denmark, contacts name: Sveina B Karlsdóttir, MD, role: CONTACT, phone: 53420448, phoneExt: 0045, email: sveina@outlook.dk, contacts name: Susanne Støvring, role: CONTACT, phone: 79406461, phoneExt: 0045, email: susanne.stoevring@rsyd.dk, geoPoint lat: 55.70927, lon: 9.5357, hasResults: False