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Clinical Trials/NCT00351494
NCT00351494
Unknown
Not Applicable

Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization

University Hospital, Tours1 site in 1 country40 target enrollmentJuly 2006
ConditionsMyoma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myoma
Sponsor
University Hospital, Tours
Enrollment
40
Locations
1
Primary Endpoint
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
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2006
End Date
June 2009
Last Updated
18 years ago
Study Type
Observational
Sex
Female

Investigators

Eligibility Criteria

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

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(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)

Study Sites (1)

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