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Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization

R

Regional University Hospital Center (CHRU)

Status

Unknown

Conditions

Myoma

Treatments

Procedure: embolization
Procedure: contrast enhanced ultrasonography

Study type

Observational

Funder types

Other

Identifiers

NCT00351494
HP06-HM/FIBROME

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Henri MARRET, Pr; Catherine ROUSSEL, ARC

Data sourced from clinicaltrials.gov

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