Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by University Hospital, Tours.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00351494
First received: July 12, 2006
Last updated: November 21, 2007
Last verified: November 2007
  Purpose

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 Intervention
Myoma
Procedure: contrast enhanced ultrasonography
Procedure: embolization

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization

Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: July 2006
Estimated Study Completion Date: June 2009
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00351494     History of Changes
Other Study ID Numbers: HP06-HM/FIBROME
Study First Received: July 12, 2006
Last Updated: November 21, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:
embolization
contrast enhanced ultrasound
myoma
uterine artery
microvascularisation

Additional relevant MeSH terms:
Myoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 11, 2014