Women with abnormal cervical screening results have colposcopic assessment that may include diagnostic biopsy or excisional treatment. We are evaluating the adjunctive use of Dynamic Spectral Imaging (DSI) that quantifies and maps the cervical acetowhitening during colposcopy.METHODS:
IMPROVE-COLPO is an on-going two-arm study on patients referred for colposcopy according to current guidelines. A prospective arm collects outcomes of colposcopy with the adjunctive DSI. A second arm will collect a matched retrospective data-set of standard colposcopy outcomes for comparisons. Here we present prospective-arm data from two community clinics in Texas. Colposcopic predictions, DSI indications and biopsies are recorded and compared with histology, using Cervical Intraepithelial Neoplasia grade 2 (CIN2+) as the disease threshold for analysis.RESULTS:
131 patients were recruited between 12/2014 and 08/2015; 130 are included (data missing for one). Histological outcomes come from 162 punch and 95 endocervical biopsies and 24 treatment specimens. High-grade dysplasia was found in 16 patients (12.30%). Only 5 of them (31.25%) were predicted as high-grade when using standard visualization (without DSI), increasing to 14 (87.50%) with the adjunctive use of the DSI assessment. Colposcopy-directed biopsy found 10 and the adjunctive DSI-guided biopsies an additional 5 of the 16 CIN2+ patients. One case was identified by excisional treatment.CONCLUSION:
The adjunctive use of the DSI mapping to predict high-grade dysplasia and select biopsy sites has led to statistically significant improvement in predictive performance and yield of CIN2+ (P=.002 and 0.025, respectively, McNemar chi-squared test).