title: Optical detection of high-grade cervical intraepithelial neoplasia in vivo: results of a 604-patient study.
abstract: OBJECTIVE
  The purpose of this study was to assess the in vivo optical detection of high-grade cervical intraepithelial neoplasia (2/3+) on the whole cervix with a noncontact, spectroscopic device.
  
  
  METHODS
  Cervical scanning devices collected intrinsic fluorescence and broadband white light spectra and video images from 604 women during routine colposcopy examinations at 6 clinical centers. A statistically significant dataset was developed of intrinsic fluorescence and white light-induced cervical tissue spectra that was correlated to expert histopathologic determination. On the basis of a retrospective analysis of the acquired data, a classification algorithm was developed, validated, and optimized.
  
  
  RESULTS
  Intrinsic fluorescence, backscattered white light, and video imaging each contribute complementary information to diagnostic algorithms for high-grade cervical neoplasia. More than 10000 measurements that were made on colposcopically identified tissue from >500 subjects were the basis for algorithm training and testing. Algorithm performance demonstrated a sensitivity of approximately 90%. This performance was confirmed by various training methods. With the use of a multivariate classification algorithm, optical detection is predicted to detect 33% more high-grade cervical intraepithelial neoplasia (2/3+) than colposcopy alone.
  
  
  CONCLUSIONS
  Full cervix optical interrogation for the detection of high-grade cervical intraepithelial neoplasia is feasible and appears capable of detecting more high-grade cervical intraepithelial neoplasia than colposcopy alone. With the use of this classification algorithm, a multisite, randomized controlled trial is underway that compares the combination of optical detection and colposcopy versus colposcopy alone.
authors.affiliation: University of Alabama at Birmingham, Birmingham, Alabama 35233-7333, USA. warner.huh@ccc.uab.edu
authors.forename: Warner K
authors.initials: WK
authors.lastname: Huh
authors.forename: Ramon M
authors.initials: RM
authors.lastname: Cestero
authors.forename: Francisco A
authors.initials: FA
authors.lastname: Garcia
authors.forename: Michael A
authors.initials: MA
authors.lastname: Gold
authors.forename: Richard S
authors.initials: RS
authors.lastname: Guido
authors.forename: Kathleen
authors.initials: K
authors.lastname: McIntyre-Seltman
authors.forename: Diane M
authors.initials: DM
authors.lastname: Harper
authors.forename: Louis
authors.initials: L
authors.lastname: Burke
authors.forename: Stephen T
authors.initials: ST
authors.lastname: Sum
authors.forename: Ross F
authors.initials: RF
authors.lastname: Flewelling
authors.forename: Ronald D
authors.initials: RD
authors.lastname: Alvarez
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000465:Algorithms; D015331:Cohort Studies; D003127:Colposcopy / Q000379:methods; D005260:Female; D005336:Fiber Optic Technology; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D013050:Spectrometry, Fluorescence / Q000379:methods*; D002583:Uterine Cervical Neoplasms / Q000473:pathology* / Q000601:surgery; D002578:Uterine Cervical Dysplasia / Q000473:pathology* / Q000601:surgery