Factors Influencing Volumetric MR-HIFU Ablation of Uterine Fibroids

Study Overview
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Brief Summary
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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.

Detailed Description
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Preprocedural predictors of treatment efficacy will be useful for excluding in advance patients who would not benefit from this treatment, thereby contributing to improved overall clinical outcomes. During ablathermy treatment lost of energy depend of tissue perfusion and thermic diffusion while energy laying depend of tissue absorption coefficient. Study these parameters before treatment could bring important information to the treatment difficulty and its efficacy. The investigators will study and compare fibroid perfusion with dynamic contrast-enhanced magnetic resonance imaging and contrast-enhanced ultrasound (CEUS). CEUS will be performed with contrast agent (SONOVUE). Thermic diffusion could be linked with fibroid stiffness. Fibroid stiffness will be quantified with velocity of shear wave measured by acoustic radiation force impulse (ARFI). Tissue absorption coefficient is correlated with the architecture and the cellularity of the tissue so the investigators think that apparent diffusion coefficient (computed with diffusion weighted imaging) could be correlated with ablathermy efficiency and other intra procedural thermal parameters.

Official Title
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Volumetric MR-HIFU Ablation of Uterine Fibroids: Factors Influencing Intraprocedural Thermal Parameters

Conditions
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Uterine Fibroid

Intervention / Treatment
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* Device: Contrast-enhancement ultrasound with Sonovue


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. 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

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient<br>Woman aged more than 18 years having one or two symptomatic fibroid with size < 15cm. | Device: Contrast-enhancement ultrasound with Sonovue<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ablathermy efficiency. | necrosis tumor volume / total volume ratio | 2 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thermal parameters | Total duration of insonification Maximal temperature peak Cooling rate Efficient thermal dose Necrosis percentage Processing speed (necrosis volume / processing time) Transmitter/fibroma distance | 2 months after inclusion | 
| Fibroid signal intensity ratio on T2. | Measurements of influence of fibroid signal intensity ratio on T2 on intraprocedural thermal parameters. | At inclusion and 2 months after inclusion | 
| Fibroids perfusion data computed with MR perfusion | Comparison fibroids perfusion data computed with MR perfusion versus contrast-enhanced ultrasound. | At inclusion | 

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