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

NCT ID: NCT07230444

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-05-31

Brief 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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

250 patients with a diagnosis of uterine fibroids who underwent uterine artery embolization

Women diagnosed with symptomatic uterine fibroids who underwent image-guided uterine artery embolization as treatment. No additional surgical or medical interventions were performed during the procedure.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Female patients ≥18 years
• Symptomatic uterine fibroids (e.g., bleeding, bulk symptoms, pain)
• Underwent UAE as definitive therapy
• Availability of baseline clinical/imaging data (for retrospective arm) or ability to provide informed consent (for prospective arm)

Exclusion Criteria

• Lack of clinical follow-up
• Poor quality or incomplete angiographic images.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Emanuele Barabino

OTHER

Sponsor Role: lead

Responsible Party

Emanuele Barabino

Emanuele Barabino, MD, EBIR - Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Giuseppe Cittadini, MD

Role: STUDY_CHAIR

IRCCS Ospedale Policlinico San Martino

Locations

IRCCS OSpedale Policlinico San Martino

Genova, Genova, Italy

Countries

Italy

Central Contacts

Emanuele Barabino, MD

Role: CONTACT

emanuele.barabino@hsanmartino.it

00393331002778

References

Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002 Feb;99(2):290-300. doi: 10.1016/s0029-7844(01)01702-1.

Reference Type: RESULT

PMID: 11814511 (View on PubMed)

Pron G, Bennett J, Common A, Wall J, Asch M, Sniderman K; Ontario Uterine Fibroid Embolization Collaboration Group. The Ontario Uterine Fibroid Embolization Trial. Part 2. Uterine fibroid reduction and symptom relief after uterine artery embolization for fibroids. Fertil Steril. 2003 Jan;79(1):120-7. doi: 10.1016/s0015-0282(02)04538-7.

Reference Type: RESULT

PMID: 12524074 (View on PubMed)

Manyonda I, Belli AM, Lumsden MA, Moss J, McKinnon W, Middleton LJ, Cheed V, Wu O, Sirkeci F, Daniels JP, McPherson K; FEMME Collaborative Group. Uterine-Artery Embolization or Myomectomy for Uterine Fibroids. N Engl J Med. 2020 Jul 30;383(5):440-451. doi: 10.1056/NEJMoa1914735.

Reference Type: RESULT

PMID: 32726530 (View on PubMed)

Other Identifiers

AI-EMBO 2.0

Identifier Type: -

Identifier Source: org_study_id