Increased detection of high-grade cervical intraepithelial neoplasia utilizing an optical detection system as an adjunct to colposcopy.

OBJECTIVE To evaluate the impact of using a novel optical detection system (ODS) as an adjunct to colposcopy. METHODS A multicenter internally controlled trial designed to evaluate the performance of an ODS system (LUMA MediSpectra, Lexington, MA) used as an adjunct to colposcopy among women referred for the evaluation of an abnormal cervical cytology result was conducted at 7 colposcopy clinics in the United States and enrolled 227 women. After exclusions, 193 women remained in the analysis. The main study outcomes were incremental increases in true positives (CIN 2,3 and cancer, or CIN 2+) and false positives (women with additional cervical biopsies not found to be CIN 2+). RESULTS Initial colposcopy identified 41 cases of CIN 2+ for a true positive (TP) rate of 21.2%. Adjunctive use of ODS identified an additional 9 cases of CIN 2+ which corresponds to an incremental ODS TP rate of 4.7% (95% CI 2.2% to 8.7%). Adjunctive use of ODS therefore resulted in a 22.0% (95% CI 6.1% to 37.8%) relative gain in the number of women with CIN 2+ compared to colposcopy alone. The false positive (FP) rate for initial colposcopy was 51.8% (100 of 193 women). An additional 35 subjects had an ODS-directed biopsy that was not diagnosed as CIN 2+, yielding an incremental FP rate of 18.1% (95% CI 13.0% to 24.3%). CONCLUSIONS Adjunctive use of ODS with colposcopy provides a significant increase in the detection of CIN 2+ in women referred for the evaluation of abnormal cytology results.

[1]  Thomas C Wright,et al.  Effective cervical neoplasia detection with a novel optical detection system: a randomized trial. , 2007, Gynecologic oncology.

[2]  Constantinos Pitris,et al.  Optical imaging of the cervix , 2003, Cancer.

[3]  D. Wilbur,et al.  Bethesda 2001 implementation and reporting rates: 2003 practices of participants in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology. , 2009, Archives of pathology & laboratory medicine.

[4]  Yvonne C Collins,et al.  Strength of correlations between colposcopic impression and biopsy histology. , 2003, Gynecologic oncology.

[5]  Sharon Thomsen,et al.  Spectroscopic diagnosis of cervical intraepithelial neoplasia (CIN) in vivo using laser‐induced fluorescence spectra at multiple excitation wavlengths , 1996, Lasers in surgery and medicine.

[6]  Y. Qiao,et al.  Colposcopically directed biopsy, random cervical biopsy, and endocervical curettage in the diagnosis of cervical intraepithelial neoplasia II or worse. , 2004, American journal of obstetrics and gynecology.

[7]  P. Bitterman,et al.  Correlation between colposcopically directed biopsy and cervical loop excision. , 1996, Gynecologic oncology.

[8]  V. Livolsi.  Blaustein's Pathology of the Female Genital Tract, 5th ed , 2002 .

[9]  Gregg Staerkel,et al.  Cervical Precancer Detection Using a Multivariate Statistical Algorithm Based on Laser‐Induced Fluorescence Spectra at Multiple Excitation Wavelengths , 1996, Photochemistry and photobiology.

[10]  Irene Georgakoudi,et al.  Trimodal spectroscopy for the detection and characterization of cervical precancers in vivo. , 2002, American journal of obstetrics and gynecology.

[11]  N Ramanujam,et al.  Development of a multivariate statistical algorithm to analyze human cervical tissue fluorescence spectra acquired in vivo , 1996, Lasers in surgery and medicine.

[12]  Thomas C Wright,et al.  Consensus Guidelines for the Management of Women With Cervical Cytological Abnormalities , 2002 .

[13]  L. Massad.  More is more: improving the sensitivity of colposcopy. , 2006, Obstetrics and gynecology.

[14]  C. Redman,et al.  Cervical cytologic abnormalities and negative colposcopy: histologic assessment , 1993, International Journal of Gynecologic Cancer.

[15]  T. Wright,et al.  Precancerous Lesions of the Cervix , 1994 .

[16]  Joan L. Walker.  A randomized trial on the management of low-grade squamous intraepithelial lesion cytology interpretations. , 2003, American journal of obstetrics and gynecology.

[17]  Thomas C Wright,et al.  2001 Consensus Guidelines for the Management of Women with Cervical Cytological Abnormalities. , 2002, Journal of lower genital tract disease.

[18]  R. Kurman,et al.  BLAUSTEIN'S PATHOLOGY OF THE FEMALE GENITAL TRACT , 2004 .

[19]  Scott B. Cantor,et al.  COLPOSCOPY FOR THE DIAGNOSIS OF SQUAMOUS INTRAEPITHELIAL LESIONS: A META‐ANALYSIS , 1998, Obstetrics and gynecology.

[20]  Colposcopy at a crossroads. , 2006 .

[21]  R Richards-Kortum,et al.  Cervical fluorescence of normal women , 1999, Lasers in surgery and medicine.

[22]  Diane Solomon,et al.  Number of Cervical Biopsies and Sensitivity of Colposcopy , 2006, Obstetrics and gynecology.

[23]  Diane M Harper,et al.  Optical detection of high-grade cervical intraepithelial neoplasia in vivo: results of a 604-patient study. , 2004, American journal of obstetrics and gynecology.

[24]  T. Krausz,et al.  Reliability of colposcopy and directed punch biopsy , 1990, British journal of obstetrics and gynaecology.

[25]  Chunsheng Jiang,et al.  Novel optical detection system for in vivo identification and localization of cervical intraepithelial neoplasia. , 2006, Journal of biomedical optics.

[26]  D. Ferris,et al.  Multimodal Hyperspectral Imaging for the Noninvasive Diagnosis of Cervical Neoplasia , 2001, Journal of lower genital tract disease.

[27]  Y. Qiao,et al.  Shanxi Province Cervical Cancer Screening Study: a cross-sectional comparative trial of multiple techniques to detect cervical neoplasia. , 2001, Gynecologic oncology.

[28]  D. Howe,et al.  Colposcopically directed punch biopsy: a potentially misleading investigation , 1992, British journal of obstetrics and gynaecology.