Dermatoscopy and reflectance confocal microscopy for basal cell carcinoma diagnosis and diagnosis prediction score: A prospective and multicenter study on 1005 lesions

Abstract

BackgroundBasal cell carcinoma is usually diagnosed by clinical and dermoscopy examination, but diagnostic accuracy may be suboptimal. Reflectance confocal microscopy (RCM) imaging increases skin cancer diagnostic accuracy. ObjectiveTo evaluate additional benefit in diagnostic accuracy of handheld RCM in a prospective controlled clinical setting MethodsA prospective, multicenter study in 3 skin cancer reference centers in Italy enrolling consecutive lesions with clinical-dermoscopic suspicion of basal cell carcinoma. Clinicaltrials.gov; NCT04789421 ResultsA total of 1005 lesions were included, of which 474 histopathologically confirmed versus 531 diagnosed by clinical-dermoscopic-RCM correlation, confirmed with 2 years of follow up. Specifically, 740 were confirmed basal cell carcinomas. Sensitivity and specificity for dermoscopy alone was 93.2% (CI 95% 91.2 - 94.9) and 51.7% (CI 95% 45.5 - 57.9); PPV was 84.4 (CI 95% 81.7 – 86.8) and NPV 73.3 (66.3 - 79.5). Adjunctive reflectance confocal microscopy reported higher rates: 97.8 (CI 95% 96.5 - 98.8) sensitivity and 86.8 (CI 95% 82.1 - 90.6) specificity, with PPV of 95.4 (CI 95% 93.6 – 96.8) and NPV 93.5 (89.7 - 96.2). LimitationsStudy conducted in one single Country ConclusionAdjunctive handheld RCM assessment of lesions clinically suspicious for basal cell carcinoma permits higher diagnostic accuracy with minimal false negative lesions.