NCT07230444

Artificial Intelligence for the Intra-procedural Assessment of Uterine Artery Embolization

Validation and Implementation With Artificial Intelligence of Software for the Intra-procedural Assessment of Uterine Artery EMBOlization

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Emanuele Barabino · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Uterine artery embolization is a minimally invasive treatment for symptomatic uterine fibroids, but intra-procedural assessment of embolization adequacy currently relies on subjective angiographic criteria. This study evaluates a proprietary angiographic analysis software (AQ-VERO) that extracts quantitative time-to-density perfusion metrics in real time. The study aims to (1) validate the accuracy and reproducibility of AQ-VERO during uterine artery mebolization, and (2) develop an AI-based decision support system using AQ-VERO-derived metrics to improve objective intra-procedural assessment of treatment endpoints.

Detailed description

Background and Rationale. Uterine fibroids affect up to 70-80% of women of reproductive age. Uterine artery embolization achieves technical success rates above 95% and symptom improvement in approximately 75-90% of patients; however, it is associated with a 20-30% cumulative risk of clinical failure or need for reintervention at 5 years. Current intra-procedural assessment of embolization adequacy is based on qualitative angiographic criteria (e.g., "5-10 heartbeats stasis," "pruned tree appearance"), which are subjective and operator-dependent. Emerging evidence suggests that achieving near-complete, rather than complete, flow stasis may reduce post-procedural pain, underscoring the need for quantitative and standardized assessment tools. AQ-VERO is an internally developed software platform that performs quantitative time-to-density (TTD) analysis of angiographic images to objectively quantify uterine and fibroid perfusion in real time. Objectives. Primary Objective: To validate the accuracy and intra-/interobserver reproducibility of AQ-VERO TTD metrics in quantifying perfusion changes during uterine artery embolization. Secondary Objectives: (a) To develop and internally validate an AI-based decision support model that uses AQ-VERO-derived metrics to identify predefined embolization endpoints; (b) To explore the correlation between intra-procedural TTD metrics and post-procedural clinical outcomes, including symptom improvement, early pain scores, and need for reintervention. Study Design. This is an ambispective (includes retrospective and prospective follow-up), multicenter observational study including women undergoing uterine artery embolization for symptomatic uterine fibroids. Standardized angiograms will be acquired and analyzed with AQ-VERO to extract TTD perfusion parameters (e.g., time-to-peak, area under the curve, wash-in/wash-out characteristics). Operators will document conventional qualitative angiographic endpoints. Clinical and imaging follow-up will be collected according to institutional protocols. Primary Objective: • To evaluate whether the AI predictive model developed using AQ-VERO© metrics can predict the clinical outcome, defined as complete or significant resolution of fibroid-related symptoms. Secondary Objectives: * To correlate distinct TTD curve morphologies and AQ-VERO metrics with post-procedural pain. * To detect the presence of collateral or accessory arterial supply that may compromise embolization efficacy. Significance. This study is expected to establish a quantitative and AI-augmented framework for intra-procedural embolization assessment during uterine artery embolization, potentially reducing variability and improving long-term clinical outcomes.

Conditions

• Uterine Fibroids (UF)

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-01
• Completion: 2027-05-31
• First posted: 2025-11-17
• Last updated: 2025-11-19

Locations

1 site across 1 country: Italy