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Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization

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ClinicalTrials.gov Identifier: NCT00351494
Recruitment Status : Unknown
Verified November 2007 by University Hospital, Tours.
Recruitment status was:  Recruiting
First Posted : July 13, 2006
Last Update Posted : November 22, 2007
Sponsor:
Information provided by:
University Hospital, Tours

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.

Condition or disease Intervention/treatment
Myoma Procedure: contrast enhanced ultrasonography Procedure: embolization

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.


Study Type : Observational
Estimated Enrollment : 40 participants
Time Perspective: Prospective
Official Title: Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization
Study Start Date : July 2006
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources


Intervention Details:
    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

    Procedure: embolization
    Intervention is described in the case report form for each patient


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Accordance between contrast-enhanced imaging and IRM [ Time Frame: inclusion period and follow-up ]
  2. 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 ]
  3. Relationship between the post embolization pain and the vascular change of the fibroma and the myometrium [ Time Frame: inclusion period ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women candidate for embolization of myomas
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00351494


Contacts
Contact: Henri MARRET, Pr (33) 2 47 47 82 59 marret@med.univ-tours.fr
Contact: Catherine ROUSSEL, ARC (33) 2 47 47 97 89 roussel@med.univ-tours.fr

Locations
France
Centre d'Innovation Technologique-Ultrasons Recruiting
Tours, France, 37344
Contact: Henri MARRET, Pr    (33) 2 47 47 82 59    marret@med.univ-tours.fr   
Contact: Catherine ROUSSEL, ARC    (33) 2 47 47 97 89    roussel@med.univ-tours.fr   
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         
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Henri MARRET, Pr Service de Gynécologie Obstétrique CHRU TOURS
Study Director: François TRANQUART, Pr Centre d'Innovation Technologique CHRU TOURS