Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization

University Hospital, Tours40 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Myoma

Interventions

contrast enhanced ultrasonographyPROCEDURE

Three contrast-enhanced ultrasonography : before embolization, after one day and after 6 months. Abdominal route 2.4 ml sonovue per injection / bolus

embolizationPROCEDURE

Intervention is described in the case report form for each patient

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre d'Innovation Technologique-Ultrasons

Tours, France

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Inclusion period and follow-up

Secondary Outcomes

Accordance between contrast-enhanced imaging and IRM

Time frame: 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

Time frame: inclusion period and follow-up

Relationship between the post embolization pain and the vascular change of the fibroma and the myometrium

Time frame: inclusion period

Central Contacts

Henri MARRET, Pr

CONTACT

(33) 2 47 47 82 59 marret@med.univ-tours.fr

Catherine ROUSSEL, ARC

CONTACT

(33) 2 47 47 97 89 roussel@med.univ-tours.fr

Data from ClinicalTrials.gov

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