Uterine Fibroids (UF)AI-EMBONCT07230444
Artificial Intelligence for the Intra-procedural Assessment of Uterine Artery Embolization
An observational study of Uterine Fibroids (UF), run by Emanuele Barabino at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Uterine Fibroids (UF)
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2025to 31 May 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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)
Who cannot join
- Lack of clinical follow-up
- Poor quality or incomplete angiographic images.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Validation and Implementation With Artificial Intelligence of Software for the Intra-procedural Assessment of Uterine Artery EMBOlization
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.
Read the 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)
- Keywords
- uterine fibroids, embolization, uterine artery embolization, quantitative imaging, artificial intelligence
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From treatment to the end of the required follow-up (6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uterine Fibroids (UF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Emanuele Barabino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emanuele Barabino, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Investigators
- Giuseppe Cittadini, MD, Study chair, IRCCS Ospedale Policlinico San Martino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230444
- Sponsor's protocol ID
- AI-EMBO 2.0
- Acronym
- AI-EMBO
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared.
Publications
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.
PubMed 11814511Pron 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.
PubMed 12524074Manyonda 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.
PubMed 32726530