Dynamic Spectral Imaging and Regular Colposcopy in CIN2+ Detection for HPV-Positive and/or Low-Grade Cytology Referrals.

Abstract

Objectives: Dynamic Spectral Imaging colposcopy (DSI), an AI-driven technology, may improve cervical cancer diagnostics. This study aimed to evaluate the cervical intraepithelial neoplasia grade 2 or worse (CIN2+) sensitivity of DSI compared to regular colposcopy in individuals referred due to human papillomavirus (HPV)-positive and/or low-grade cytology.

Methods: This multicenter comparative cross-sectional study included individuals aged ≥18 years referred for colposcopy due to HPV positivity and/or low-grade cytology. Participants underwent either DSI or regular colposcopy. Colposcopists first identified the most suspicious area; in the DSI group, this was done before reviewing the DSI color map. The worst colored area was then selected, followed by additional biopsies. All participants had 4 cervical biopsies taken, with the most severe diagnosis as the gold standard. The primary outcome was CIN2+ detection sensitivity comparison between groups using a chi-square test.

Results: A total of 411 individuals underwent examination with DSI and 308 had regular colposcopy. The sensitivity for detecting CIN2+ with DSI was 69.3% (95% CI = 61.2-76.7) with an average of 1.3 biopsies, comparable to the sensitivity of the regular group when 2 biopsies were taken (68.3%, 95% CI = 58.3-77.2). No significant sensitivity differences were observed between groups when 3 or 4 biopsies were combined.

Conclusion: The DSI color map did not show a clinically significant improvement in CIN2+ detection sensitivity compared to regular colposcopy. However, multiple biopsies enhanced sensitivity and remained superior for CIN2+ detection in both colposcopy groups.