title: Dynamic spectral imaging colposcopy: higher sensitivity for detection of premalignant cervical lesions.
abstract: 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.
  
  
  METHODS
  prospective, comparative, multicentre clinical trial.
  
  
  METHODS
  the colposcopy clinics of three Dutch hospitals.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.affiliation: Department of Pathology, VU University Medical Centre, Amsterdam, Netherlands.
authors.forename: Ja
authors.initials: J
authors.lastname: Louwers
authors.forename: A
authors.initials: A
authors.lastname: Zaal
authors.forename: M
authors.initials: M
authors.lastname: Kocken
authors.forename: Wa
authors.initials: W
authors.lastname: Ter Harmsel
authors.forename: Gcm
authors.initials: G
authors.lastname: Graziosi
authors.forename: Jwm
authors.initials: J
authors.lastname: Spruijt
authors.forename: J
authors.initials: J
authors.lastname: Berkhof
authors.forename: C
authors.initials: C
authors.lastname: Balas
authors.forename: E
authors.initials: E
authors.lastname: Papagiannakis
authors.forename: Pjf
authors.initials: P
authors.lastname: Snijders
authors.forename: Cjlm
authors.initials: C
authors.lastname: Meijer
authors.forename: Fj
authors.initials: F
authors.lastname: van Kemenade
authors.forename: Rhm
authors.initials: R
authors.lastname: Verheijen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003127:Colposcopy / Q000295:instrumentation / Q000379:methods*; D003952:Diagnostic Imaging / Q000379:methods*; D004867:Equipment Design; D005260:Female; D006801:Humans; D008875:Middle Aged; D011230:Precancerous Conditions / Q000175:diagnosis*; D012680:Sensitivity and Specificity; D013057:Spectrum Analysis; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis*