Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroids (UF) | Uterine Corpus Leiomyoma | ALIAS | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 250 patients with a diagnosis of uterine fibroids who underwent uterine artery embolization
- description
- 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.
Primary outcomes (1)
- measure
- The primary outcome measure is the AUPRC of the predictive models.
- timeFrame
- From treatment to the end of the required follow-up (6 months).
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (3)
- RESULTSpies 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
- RESULTPron 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
- RESULTManyonda 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