title: Results of a pilot study of multispectral digital colposcopy for the in vivo detection of cervical intraepithelial neoplasia.
abstract: OBJECTIVE
  Fluorescence spectroscopy is a promising technology for the detection of cervical squamous intraepithelial precancers and cancers. To date, many investigators have focused on point spectroscopy as an adjunct to diagnostic colposcopy. A device that visualizes the whole field of the cervix is needed for screening. To that end, we have developed a multispectral digital colposcope that works through the colposcope to image with white light, UV excitation at 345 nm, and blue light at 440 nm excitation. Here, we report the pilot study that precedes a Phase I trial.
  
  
  METHODS
  The MDC system is composed of a light source, a colposcope, and a video rate color CCD camera with a frame grabber and takes approximately less than 1 min to make images of the cervix. Patients were measured at baseline and after acetic acid placement with white light, 345 nm excitation, and 440 nm excitation from the xenon arc lamp. The white light is in the visible spectrum, 345 nm excitation is in the UV spectrum and is not visible, and 440 nm excitation is blue light in the visible spectrum. White light generates a pink image of the cervix. 345 nm excitation, the UV light, excites fluorophores to emit a blue image. 440 nm excitation, the blue light, excites fluorophores to emit a green image. The patients underwent a loop excision procedure and the histopathology was inked and cut into 12 sections by the study pathologists. The histopathologic slides were scanned and the images were then reconstructed into maps. A diagnostic algorithm was calculated. The data were preprocessed, transformed, and analyzed by the K-means clustering method. Disease maps were generated using the algorithm and classifier and compared to white light colposcopy and the blue and green images obtained at 345 and 440 nm.
  
  
  RESULTS
  Forty-six patients were measured at four clinical sites. Images were made of the cervix with white light, 345 nm excitation, and 440 nm excitation and are presented in the figures. As the study went on, images improved with improvements in the instrument. The white light and fluorescence images are presented with crudely constructed histopathologic maps and algorithmic maps. At 345 nm excitation, the UV light, histologically confirmed CIN appears darker blue; while at 440 nm excitation, the blue light, histologically confirmed CIN appears lighter green.
  
  
  CONCLUSIONS
  This pilot study shows that MDC images can be matched to both histopathologic and algorithmic maps. The device and the algorithm are evolving but show promise. A Phase I trial is planned.
authors.affiliation: Center for Biomedical Engineering, Department of Biostatistics and Applied Mathematics, The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030, USA.
authors.forename: Andrea
authors.initials: A
authors.lastname: Milbourne
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Park
authors.forename: J Louis
authors.initials: JL
authors.lastname: Benedet
authors.forename: Dianne
authors.initials: D
authors.lastname: Miller
authors.forename: Thomas
authors.initials: T
authors.lastname: Ehlen
authors.forename: Helen
authors.initials: H
authors.lastname: Rhodes
authors.forename: Anais
authors.initials: A
authors.lastname: Malpica
authors.forename: Jasenka
authors.initials: J
authors.lastname: Matisic
authors.forename: Dirk
authors.initials: D
authors.lastname: Van Niekirk
authors.forename: E Neely
authors.initials: EN
authors.lastname: Atkinson
authors.forename: Natalie
authors.initials: N
authors.lastname: Hadad
authors.forename: Nick
authors.initials: N
authors.lastname: Mackinnon
authors.forename: Calum
authors.initials: C
authors.lastname: Macaulay
authors.forename: Rebecca
authors.initials: R
authors.lastname: Richards-Kortum
authors.forename: Michele
authors.initials: M
authors.lastname: Follen
mesh_terms: D000328:Adult; D000368:Aged; D000465:Algorithms; D020681:Colposcopes; D003127:Colposcopy / Q000379:methods*; D005260:Female; D006801:Humans; D007091:Image Processing, Computer-Assisted; D008875:Middle Aged; D010865:Pilot Projects; D013050:Spectrometry, Fluorescence / Q000379:methods; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis*