Preliminary results from multi-center clinical trials for detection of cervical squamous intraepithelial lesions using a novel full-field evoked tissue fluorescence based imaging instrument

摘要

We report preliminary results form a multi-center trial of evaluating the performance of a novel, full-field multi-spectral tissue fluorescence imaging system (Cerviscan~(TM)) designed to detect cervical squamous intraepithelial lesions. Spectral data from multiple regions of 48 patients enrolled from clinical performance sites in the US and Canada are included in this preliminary analysis. This includes 30 women used for the training set and 18 used for the testing set. In the testing set, 37/43 SIL and 70/80 NonSIL regions were correctly identified for a sensitivity of 86% and specificity of 87.5%. Cerviscan~(TM) locates cervical precancerous lesions with high sensitivity and specificity and has the potential to permit 'see and treat' patient management.