MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids

Study Overview
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Brief Summary
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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

Detailed Description
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Pre-procedural predictors of treatment efficacy will be useful for excluding in advance patients who would not get benefit of this treatment. It seems that elastography, cellular density and perfusion could be considered as predictors. Fibroid elastography will be quantified by MRE Resoundant® system and pelvic ultrasound. Perfusion and cellular density will be quantified by MR diffusion.

Official Title
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MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids

Conditions
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Uterine Fibroid

Intervention / Treatment
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* Device: Myoma elastography


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myoma elastography<br>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. | Device: Myoma elastography<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite criteria | Composite criteria measured from: myoma stiffness (measured by Resoundant system) and ablathermy efficiency. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| leiomyoma stiffness measured by Resoundant system | leiomyoma stiffness measured by Resoundant system | Baseline | 
| leiomyoma stiffness measured by ARFI-US | leiomyoma stiffness measured by ARFI-US | Baseline | 
| clinical efficiency | Defined as a decrease of 10pts on UFS-Qol score | month 6 | 
| inter-observer reproducibility | inter-observer reproducibility of leiomyoma stiffness measurements by Resoundant system | Baseline | 
| leiomyoma perfusion | leiomyoma perfusion (diffusion) | Month 6 | 
| leiomyoma T2 signal | It will be evaluated in two ways: The first consists of a qualitative analysis taking as a reference the signal of the paravertebral muscles. Myomas will then be classified into a hypersignal, iso-signal or hyposignal group as compared to muscles (qualitative method according to the classification of Funaki). The second will be a quantitative method. One ROI will be positioned in the myoma and a second in the paravertebral muscle and the ratio of these values will be recorded. | Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibroid treatment, HIFU, MR elastography, Perfusion, Diffusion weighted imaging, ARFI, Fibroid stiffness