Clinical trial · Interventional
MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids
NCT04345003CI-TRIAL-00113025ELASTUScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 for fibroids is an outpatient approach for controlling symptom with an excellent safety record. It is important to exclude in advance patients who would not benefit from this treatment. For that purpose this study assesses the influence of fibroid elasticity and diffusion on ablation efficiency during 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 |
|---|---|---|---|
| Myoma elastography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Myoma elastography
- description
- The standard pre-therapeutic assessment includes a pelvic US to eliminate the presence of calcification of fibroids. If this absence is confirmed, the elasticity of uterine myoma (by ARFI method) will be measured. The standard pre-therapeutic MRI performed allows to classify and measure the myoma in order to determine if it is accessible for HIFU treatment. MRI elastography sequence with the Resoundant® system will be performed during this exam.
- interventionNames
- Device: Myoma elastography
Primary outcomes (1)
- measure
- Composite criteria
- timeFrame
- Baseline
- description
- Composite criteria measured from: * myoma stiffness (measured by Resoundant system) and * ablathermy efficiency.
Secondary outcomes (6)
- measure
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. * Leiomyoma type Funaki 1 or 2 on pre-therapeutic MRI * Normal cervicovaginal smear performed within 2 years prior to inclusion * Myoma technically accessible to MR-HIFU treatment verified on pre-therapeutic MRI * SSS score on UFS-Qol ≥ 10 * Signed informed consent prior to any study related procedure * With a medical insurance Exclusion Criteria: * Contraindicated to MR examination, gadolinium contrast injection (pregnancy etc..). * Presence or suspicious of pelvic malignant tumor * Myomas causing haemorrhage (meno-metrorrhagia) associated with anemia (Hb \<10g/dl) * Pregnant or lactating woman * Small submucous myoma accessible for hysteroscopic treatment. * Active pelvic infection * Presence of calcification, surgical staples, or rigid implant in the passage of the ultrasound beamo People placed under legal protection, or participating in another research protocol including an exclusion period still in progress at pre-inclusion.
References
Publications (0)
Data not yet available
No reference posted for this study.