Optical detection of cervical neoplasia: Results from an internally-controlled multicenter study

Abstract

Background. More than 30% of high-grade cervical intraepithelial neoplasia (CIN 2,3) may be missed at colposcopy. Novel optical detection system (ODS) offer the potential of improving the performance of colposcopy. Our group has now completed three multicenter trails to evaluate ODS as an aid in the detection and localization of CIN 2,3 sites for cervical biopsy. In the most recent study, a single-arm internally-controlled trial comparing colposcopy with and without the benefit of ODS was evaluated. Methods. Women referred to colposcopy with an abnormal Pap test were evaluated by colposcopy with commitment to biopsy sites. Prior to biopsy, an ODS scan was performed to identify additional biopsy sites. The ODS combines fluorescence, white light backscattered spectroscopy, and video imaging in a hyperspectral detection algorithm (MediSpectra, Inc., Lexington, MA). ODS results are displayed as a colored overlay on a cervical image depicting areas suspect for CIN 2,3 to guide additional biopsies. Distinct colposcopy-directed and incremental ODS-directed biopsies were evaluated by reference pathology for the presence of CIN 2,3. Results. Of 227 enrolled subjects at 7 clinical sites, data from 193 were evaluable. Referral Pap distribution was 39.4% ASCUS, 47.2% LSIL, and 13.5% HSIL. Colposcopy detected 41 cases of CIN 2,3, and ODS detected an additional 9 cases, for a 22% gain ( P = 0.0037). For the ASCUS/LSIL group, initial colposcopy detected 24 cases of CIN 2,3, and the ODS detected an additional 6, for a 25% gain ( P = 0.0214). Conclusions. ODS increased the detection of CIN 2,3 by 25% among women with ASCUS/LSIL cytology referred to colposcopy. These results are in agreement with a prior dual-arm randomized controlled trial evaluating ODS in an intended use setting comprising 2299 women.