Clinical trial · Interventional
Factors Influencing Volumetric MR-HIFU Ablation of Uterine Fibroids
Volumetric MR-HIFU Ablation of Uterine Fibroids: Factors Influencing Intraprocedural Thermal Parameters
- 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)
Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation is increasingly being used worldwide to treat symptomatic uterine fibroids because of its excellent therapeutic efficacy in controlling symptoms and its excellent safety record. Despite the benefits, it should be recognized that MR HIFU ablation does not always yield good therapeutic outcomes. High signal intensity on T2-weighted MR images and a high volume transfer constant (or Ktrans) on dynamic contrast material-enhanced MR images are the most well-known risk factors for poor ablation outcomes as measured with the non-perfused volume (NPV) ratio (ie, NPV divided by fibroid volume). The aim of this study is to assess the influence of fibroid perfusion (evaluated by MRI and contrast enhanced ultrasound), apparent diffusion coefficient (evaluated by MR-diffusion imaging) and fibroid stiffness (evaluated by ARFI) on ablation efficiency during uterine fibroid treatment by MR-HIFU.
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 Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-enhancement ultrasound with Sonovue | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patient
- description
- Woman aged more than 18 years having one or two symptomatic fibroid with size \< 15cm.
- interventionNames
- Device: Contrast-enhancement ultrasound with Sonovue
Primary outcomes (1)
- measure
- Ablathermy efficiency.
- timeFrame
- 2 months after inclusion
- description
- necrosis tumor volume / total volume ratio
Secondary outcomes (3)
- measure
- Thermal parameters
- timeFrame
- 2 months after inclusion
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Woman * Aged more than 18 years * Not postmenopausal * Having one or two symptomatic fibroid with size \< 15cm. * Symptoms Severity Score (SSS) score on Uterine Fibroid Symptoms related Quality of Life (UFS-Qol) ≥ 10 * Signed informed consent prior to any study related procedure * With a medical insurance Exclusion Criteria: * Contraindicated to MR examination, SONOVUE and gadolinium contrast injection (pregnancy etc..). * Presence or suspicious of pelvic malignant tumor
References
Publications (1)
- RESULTHocquelet A, Denis de Senneville B, Frulio N, Salut C, Bouzgarrou M, Papadopoulos P, Trillaud H. Magnetic resonance texture parameters are associated with ablation efficiency in MR-guided high-intensity focussed ultrasound treatment of uterine fibroids. Int J Hyperthermia. 2017 Mar;33(2):142-149. doi: 10.1080/02656736.2016.1241432. Epub 2016 Oct 28. PMID 27790950