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Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization

Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00351494
Enrollment
40
Registered
2006-07-13
Start date
2006-07-31
Completion date
2009-06-30
Last updated
2007-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myoma

Keywords

embolization, contrast enhanced ultrasound, myoma, uterine artery, microvascularisation

Brief summary

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

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.

Interventions

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

PROCEDUREembolization

Intervention is described in the case report form for each patient

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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 embolizationInclusion period and follow-up

Secondary

MeasureTime frame
Accordance between contrast-enhanced imaging and IRMinclusion 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 monthinclusion period and follow-up
Relationship between the post embolization pain and the vascular change of the fibroma and the myometriuminclusion period

Countries

France

Contacts

Primary ContactHenri MARRET, Pr
marret@med.univ-tours.fr(33) 2 47 47 82 59
Backup ContactCatherine ROUSSEL, ARC
roussel@med.univ-tours.fr(33) 2 47 47 97 89

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026