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Preliminary Experimental Results from Multi-Center Clinical Trials for Detection of Cervical Precancerous Lesions Using the Cerviscan(TM) System: A Novel Full-Field Evoked Tissue Fluorescence Based Imaging Instrument

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Cervical cancer is an important cause of death in women worldwide. Women are currently screened for cervical cancer using Pap smear-an imperfect technology with poor sensitivity and specificity. Furthermore, 5-10 of the Pap smear studies result in uncertain findings called ASCUS, These patients are subjected to repeat Pap smears to determine women who need further examination by colposcopy. LifeSpex, Inc., is developing the CerviscanTM system-a novel, full-field multi-spectral tissue fluorescence imaging system that is designed to detect cervical precancerous lesions i.e. SIL in real-time, We report preliminary results from a multi-center trial for evaluating the performance of CerviscanTM system. A study population of 67 subjects, in three clinical sites in the US and Canada, each underwent three procedures a repeat liquid-based Pap smear, b Cerviscan exam, and c colposcopy directed biopsy exam gold standard. Fifty-two patients for whom data from all three exams were available i.e. 78 of the patients enrolled are included in this preliminary analysis. A multivariate classification algorithm has been trained using data from 228 regions 82 SIL, 146 NonSIL in 42 women. Results are reported on an independent test set of 70 regions 25 SIL, 45 NonSIL in 10 women. The CerviscanTM system correctly identified 2125 SIL and 4245 NonSIL regions, giving a sensitivity of 84 and specificity of 93.3. The CerviscanTM system correctly resolved 57 ASCUSLoSIL calls made by repeat liquid-based cytology. The CerviscanTM system detects precancerous lesions with higher accuracy than repeat liquid-based Pap smear and locates lesion in real-time.

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  • Medicine and Medical Research

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