Back to Search Start Over

Multimodal hyperspectroscopy as a triage test for cervical neoplasia: Pivotal clinical trial results

Authors :
Nahida Chakhtoura
Lisa Flowers
Marc L. Winter
Edward J. Wilkinson
Alexander F. Burnett
Daniel R. Sternfeld
Manocher Lashgari
L.B. Twiggs
Stephen S. Raab
Daron G. Ferris
Source :
Gynecologic Oncology. 130:147-151
Publication Year :
2013
Publisher :
Elsevier BV, 2013.

Abstract

Objective To prospectively evaluate a new non invasive device that combines fluorescence and reflectance spectroscopy in a population in women at risk for cervical dysplasia. Methods A total of 1607 women were evaluated with multimodal hyperspectroscopy (MHS), a painless test with extremely high spectral resolution. Subjects who were referred to colposcopy based on abnormal screening tests or other referral criteria underwent the MHS test and also had a sample taken for additional cytology and presence of high risk human papilloma virus (HPV) prior to undergoing biopsy. Results Sensitivity of MHS for cervical intraepithelial neoplasia (CIN) 2+ was 91.3% (252/276). Specificity, or the potential reduction in referrals to colposcopy and biopsy, was 38.9% (222/570) for women with normal or benign histology and 30.3% (182/601) for women with CIN1 histology. Two year follow-up data, collected for a subgroup of 804 women, revealed 67 interval CIN2+ that originally were diagnosed at enrollment as normal or CIN1. MHS identified 60 of these (89.6%) as positive for CIN2+ prior to their discovery during the two year follow-up period. Conclusions MHS provides an immediate result at the point of care. Recently, the limitations of cytology have become more obvious and as a consequence greater emphasis is being placed on HPV testing for cervical cancer screening, creating a need for an inexpensive, convenient and accurate test to reduce false positive referrals to colposcopy and increase the yield of CIN2+ at biopsy. MHS appears to have many of the attributes necessary for such an application.

Details

ISSN :
00908258
Volume :
130
Database :
OpenAIRE
Journal :
Gynecologic Oncology
Accession number :
edsair.doi.dedup.....89398587efe2a74e3730ba93458475d8
Full Text :
https://doi.org/10.1016/j.ygyno.2013.04.012