Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization
Recruitment status was Recruiting
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization|
- 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 ]
- 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 ]
|Study Start Date:||July 2006|
|Estimated Study Completion Date:||June 2009|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351494
|Contact: Henri MARRET, Pr||(33) 2 47 47 82 firstname.lastname@example.org|
|Contact: Catherine ROUSSEL, ARC||(33) 2 47 47 97 email@example.com|
|Centre d'Innovation Technologique-Ultrasons||Recruiting|
|Tours, France, 37344|
|Contact: Henri MARRET, Pr (33) 2 47 47 82 59 firstname.lastname@example.org|
|Contact: Catherine ROUSSEL, ARC (33) 2 47 47 97 89 email@example.com|
|Sub-Investigator: François TRANQUART, Pr|
|Sub-Investigator: Aurore BLEUZEN, MD|
|Sub-Investigator: Denis HERBRETEAU, Pr|
|Sub-Investigator: Marc LEGEAIS, MD|
|Sub-Investigator: Nathalie WAGNER, MD|
|Principal Investigator:||Henri MARRET, Pr||Service de Gynécologie Obstétrique CHRU TOURS|
|Study Director:||François TRANQUART, Pr||Centre d'Innovation Technologique CHRU TOURS|