{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T00:03:14Z","timestamp":1788998594130,"version":"build-2803163510"},"reference-count":25,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T00:00:00Z","timestamp":1779148800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T00:00:00Z","timestamp":1779148800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Lasers Surg Med"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>We prospectively enrolled 131 lesions of 104 patients to confirm or rule out the diagnosis of BCC. Dermoscopy, line\u2010field optical coherence tomography (LC\u2010OCT), and Reflectance confocal microscopy 1500 (RCM) images were evaluated by one blinded expert (OM).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>The primary objective of this study was to assess the diagnostic performance of LC\u2010OCT in lesions clinically suspicious for basal cell carcinoma (BCC), by determining the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of this technique. Diagnostic performances were evaluated in two distinct real\u2010life settings: lesions for which tissue\u2010coupled reflectance confocal microscopy (RCM) served as the reference standard, and lesions for which histopathological examination following biopsy was used as the reference standard. The secondary objectives were to assess clinician confidence when using dermoscopy, LC\u2010OCT, and RCM, and to estimate the agreement rate between LC\u2010OCT and RCM findings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Design: Single\u2010center, nonrandomized, blinded, prospective, observational study.<\/jats:p>\n                    <jats:p>Setting: OptiSkin.<\/jats:p>\n                    <jats:p>Participants: Patients with Fitzpatrick Skin Types I\u2010IV between the ages of 29\u201392 years from OptiSkin are eligible for this study.<\/jats:p>\n                    <jats:p>Measurements: Clinical, dermoscopic, and LC\u2010OCT images were obtained for all subjects. Further, measurements on the lesion included either an RCM examination or a traditional cutting biopsy, depending on body location, insurance coverage, or patient preference. At each stage, the clinician provided her confidence level in her diagnosis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 131 lesions clinically suspicious for BCC were imaged with LC\u2010OCT in 104 patients. LC\u2010OCT successfully imaged all 131 lesions, including those in challenging anatomical regions inaccessible to RCM, such as the nose.<\/jats:p>\n                    <jats:p>Primary objective: Tissue\u2010coupled RCM was performed on 63 lesions, for which LC\u2010OCT achieved 95.9% sensitivity, 85.7% specificity, and 93.7% accuracy (PPV 95.9%, NPV 85.7%). This analysis revealed four disagreements: two FN and two FP.<\/jats:p>\n                    <jats:p>The remaining 68 lesions, diagnosed with histology, showed 86.4% sensitivity, 79.2% specificity, and 83.8% accuracy (PPV 88.4%, NPV 76.0%). This analysis revealed 11 disagreements, 6 FN, and 5 FP. Using RCM or histology when available as the gold standard, LC\u2010OCT had an overall sensitivity of 91.2%, specificity of 77.50%, and accuracy of 86.92%.<\/jats:p>\n                    <jats:p>Secondary Objective: For the 63 lesions evaluated with both LC\u2010OCT and RCM, the agreement rate was 93.6% (Cohen's Kappa 0.81), with only 4 diagnostic discrepancies (2 FN and 2 FP). High\u2010confidence LC\u2010OCT diagnoses (\u2265\u20098\/10) achieved 100% sensitivity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Our findings demonstrate that LC\u2010OCT provides high sensitivity, specificity, accuracy, PPV, and NPV when tested against both tissue\u2010coupled RCM and histopathology. LC\u2010OCT was easy to use in challenging facial regions where the RCM device can be difficult to operate. This high diagnostic accuracy suggests that LC\u2010OCT may reduce the need for immediate biopsy, streamline clinical decision\u2010making, and minimize scarring, thereby improving cosmetic outcomes. Although the widespread adoption of LC\u2010OCT in the United States remains limited by current reimbursement barriers, this technology has the potential to become an essential tool in modern dermatologic oncology.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/lsm.70146","type":"journal-article","created":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T11:46:05Z","timestamp":1779191165000},"page":"532-540","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A Prospective, Observational Study Evaluating the Diagnostic Performance of a Newly FDA\u2010Approved Line\u2010Field Optical Coherence Tomography (LC\u2010OCT) in the Detection of Basal Cell Carcinoma"],"prefix":"10.1002","volume":"58","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-3803-3216","authenticated-orcid":false,"given":"Aisling","family":"O'Donnell","sequence":"first","affiliation":[{"name":"OptiSkin Medical Columbia University New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6317-2374","authenticated-orcid":false,"given":"Halima","family":"Amro","sequence":"additional","affiliation":[{"name":"OptiSkin Medical Columbia University New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-9947-6456","authenticated-orcid":false,"given":"Thu Anh","family":"Ly","sequence":"additional","affiliation":[{"name":"OptiSkin Medical Columbia University New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3668-8631","authenticated-orcid":false,"given":"Orit","family":"Markowitz","sequence":"additional","affiliation":[{"name":"OptiSkin Medical Columbia University New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,5,19]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"Our New Approach to a Challenging Skin Cancer Statistic. The Skin Cancer Foundation https:\/\/www.skincancer.org\/blog\/our-new-approach-to-a-challenging-skin-cancer-statistic\/."},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.2147\/ott.s130371"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jid.2021.09.029"},{"issue":"10","key":"e_1_2_11_5_1","first-page":"0","article-title":"Evaluation of Optical Coherence Tomography as a Means of Identifying Earlier Stage Basal Cell Carcinomas While Reducing the Use of Diagnostic Biopsy","volume":"8","author":"Markowitz O.","year":"2015","journal-title":"Journal of Clinical and Aesthetic Dermatology"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.13853"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD013189"},{"key":"e_1_2_11_8_1","unstructured":"Optical Coherence Tomography in Dermatology. Mdedge.com. Published January 10 2019 https:\/\/www.mdedge.com\/dermatology\/article\/146053\/melanoma\/optical-coherence-tomography-dermatology."},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD013191"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/lsm.22600"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdcr.2018.09.019"},{"key":"e_1_2_11_12_1","unstructured":"VivaScope System. Caliberid.com Published2024 https:\/\/caliberid.com\/vivascope-system.html."},{"key":"e_1_2_11_13_1","unstructured":"VivaScope 1500 and 3000 imaging systems for detecting skin cancer lesions. nice.org.uk. November 11 2015 https:\/\/www.nice.org.uk\/guidance\/dg19\/chapter\/5-outcomes?utm_."},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.12780"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1159\/000354762"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2019.02.049"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2014.04.067"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2004.06.028"},{"key":"e_1_2_11_19_1","unstructured":"U.S. Food and Drug Administration. 510(k) Premarket Notification accessed July 23rd 2025 https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm?ID=K240610."},{"key":"e_1_2_11_20_1","unstructured":"DAMAE MEDICAL. damae\u2010medical.com https:\/\/damae-medical.com\/."},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.3390\/cancers14041082"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.17078"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2133.1999.03111.x"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.4103\/0974-2077.146660"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.3390\/cancers17050826"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.3390\/curroncol30100639"}],"container-title":["Lasers in Surgery and Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/lsm.70146","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/lsm.70146","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/lsm.70146","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T18:09:13Z","timestamp":1786558153000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/lsm.70146"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,19]]},"references-count":25,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1002\/lsm.70146"],"URL":"https:\/\/doi.org\/10.1002\/lsm.70146","archive":["Portico"],"relation":{},"ISSN":["0196-8092","1096-9101"],"issn-type":[{"value":"0196-8092","type":"print"},{"value":"1096-9101","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,19]]},"assertion":[{"value":"2025-07-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-05-02","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-05-19","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}