Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization

Study Overview
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Brief Summary
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Contrast-enhanced ultrasound is supposed to improve the detection of myomas as well as improve the follow-up after specific treatments like embolization. It will also help the investigators better understand the mechanism of success or failure for embolization and could reduce the amount of particles injected by determining the endpoint of the procedure in order to treat the myomas while preserving the myometrium.

Detailed Description
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Before embolization of the uterine artery, 40 patients with unique or multiple myomas will be included prospectively in our study and evaluated with sonography before and after injection of Sonovue (2.4 ml) (Bracco Int Milano Italy). Pelvic ultrasound with contrast enhancement will be done the day after and six months after the procedure. Microvascularization of the myomas and the endometrium will be described. Some tiny myomas which are not visible on conventional sonography could be identified for a perfect matching with MRI detection.

Official Title
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Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization

Conditions
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Myoma

Intervention / Treatment
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* Procedure: contrast enhanced ultrasonography
* Procedure: embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Uterine myomas with solid tissue (greater diameter lower than 15 cm) The embolization is planified during the 15 days after the contrast ultrasonography Written informed consent is signed Exclusion Criteria: Intracavitary uterine mass possibly due to a polyp or endometrial cancer Necessity of using the endovaginal way of ultrasonography because of the myoma's size and accessibility Menopause Pregnancy and breastfeeding Recent cardiac affection History of acute cardiac disease

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: contrast enhanced ultrasonography|Three contrast-enhanced ultrasonography : before embolization, after one day and after 6 months. Abdominal route 2.4 ml sonovue per injection / bolus|
|Procedure: embolization|Intervention is described in the case report form for each patient|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the usefulness of contrast-enhanced ultrasound with real-time imaging technique in the assessment of vascular patterns from myomas myometrium and ovaries before and after uterine artery embolization |  | Inclusion period and follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accordance between contrast-enhanced imaging and IRM |  | inclusion period and follow-up | 
| Accordance between early vascular patterns due to embolization of the fibroma and the success of the technique which is evaluated after 6 month |  | inclusion period and follow-up | 
| Relationship between the post embolization pain and the vascular change of the fibroma and the myometrium |  | inclusion period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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embolization, contrast enhanced ultrasound, myoma, uterine artery, microvascularisation