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

NCT07230444 | Not Yet Recruiting

• 1 other identifier: AI-EMBO 2.0
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Fibroids (UF)

Keywords

uterine fibroids; embolization; uterine artery embolization; quantitative imaging; artificial intelligence

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the AUPRC of the predictive models.

  The Area Under the Precision-Recall Curve (AUPRC) will be calculated to evaluate the performance of the AI-based decision support model in identifying clinically relevant embolization endpoints. AUPRC is a threshold-independent metric that summarizes the tradeoff between precision (positive predictive value) and recall (sensitivity) across all decision thresholds. It is particularly suitable for imbalanced datasets, where positive outcome events may be less frequent. Higher AUPRC values indicate better discriminative performance of the model.

  From treatment to the end of the required follow-up (6 months).

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult female patients aged 18 to 55 years with symptomatic uterine fibroids who underwent or are undergoing uterine artery embolization as their primary treatment. All participants must have angiographic imaging suitable for quantitative analysis and a minimum of 6 months of available clinical follow-up.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Emanuele Barabino: lead

Study Sites (1)

IRCCS OSpedale Policlinico San Martino

Genova, Genova, 16100, Italy

Location

Related Publications (3)

• 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.

  PMID: 11814511 RESULT

• 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.

  PMID: 12524074 RESULT

• 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.

  PMID: 32726530 RESULT

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Giuseppe Cittadini, MD

  IRCCS Ospedale Policlinico San Martino

  STUDY CHAIR

Central Study Contacts

Emanuele Barabino, MD

CONTACT

00393331002778; emanuele.barabino@hsanmartino.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Emanuele Barabino, MD, EBIR - Principal Investigator

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)