Objective To validate the dynamic spectral imaging (DSI) colposcope's colour-coded map in discriminating high- from low-grade cervical lesions and non-neoplastic tissue. Design Prospective, comparative, multicentre clinical trial. Setting The colposcopy clinics of three Dutch hospitals. Population Women of 18 years or over with an intact cervix, referred for colposcopy. Methods During a 3-minute image acquisition phase, the DSI colposcope was used as a regular video colposcope: the colposcopist located and graded potential lesions based on conventional colposcopic criteria. Subsequently, a colour-coded map was calculated and displayed, representing localisation and severity of the cervical lesion. Biopsies were collected from all atypical sites, as identified by digital mapping and/or conventional colposcopy. Furthermore, one additional biopsy was taken. Main outcome measures Histologically confirmed high-grade cervical disease (CIN2+). Results In total 275 women were included in the study: 183 women were analysed in the 'according-to-protocol' (ATP) cohort and 239 women in the 'intention-to-treat' (ITT) cohort. In the ATP cohort, the sensitivity of DSI colposcopy to identify women with high-grade (CIN2+) lesions was 79% (95% CI 70-88) and the sensitivity of conventional colposcopy was 55% (95% CI 44-65) (P = 0.0006, asymptotic McNemar test). When the DSI colour-coded map was combined with conventional colposcopy, the sensitivity was 88% (95% CI 82-95). Conclusions DSI colposcopy has a significantly higher sensitivity to detect cervical lesions than conventional colposcopy. If the colour-coded map is combined with conventional colposcopic examination, the sensitivity increases further.

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Keywords Cervical Intraepithelial neoplasia, adult, article, clinical trial, cohort analysis, colposcopy, controlled study, dynamic spectral imaging colposcopy, female, histopathology, human, human tissue, major clinical study, multicenter study, premalignant cervical lesion, priority journal, sensitivity, sensitivity analysis, specificity, spectrometry, uterine cervix disease
Persistent URL dx.doi.org/10.1111/j.1471-0528.2010.02806.x, hdl.handle.net/1765/22913
Journal BJOG: An International Journal of Obstetrics and Gynaecology
Louwers, J.A, Zaal, A, Kocken, M, ter Harmsel, W.A, Graziosi, G.C.M, Spruijt, J.W.M, … Verheijen, R.H.M. (2011). Dynamic spectral imaging colposcopy: Higher sensitivity for detection of premalignant cervical lesions. BJOG: An International Journal of Obstetrics and Gynaecology, 118(3), 309–318. doi:10.1111/j.1471-0528.2010.02806.x