Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization

November 21, 2007 updated by: University Hospital, Tours
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37344
        • Recruiting
        • Centre d'Innovation Technologique-Ultrasons
        • Sub-Investigator:
          • François TRANQUART, Pr
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Aurore BLEUZEN, MD
        • Sub-Investigator:
          • Denis HERBRETEAU, Pr
        • Sub-Investigator:
          • Marc LEGEAIS, MD
        • Sub-Investigator:
          • Nathalie WAGNER, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women candidate for embolization of myomas

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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 embolization
Time Frame: Inclusion period and follow-up
Inclusion period and follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Accordance between contrast-enhanced imaging and IRM
Time Frame: inclusion period and follow-up
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
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
inclusion period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Study Director: François TRANQUART, Pr, Centre d'Innovation Technologique CHRU TOURS
  • Principal Investigator: Henri MARRET, Pr, Service de Gynécologie Obstétrique CHRU TOURS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

July 12, 2006

First Submitted That Met QC Criteria

July 12, 2006

First Posted (Estimate)

July 13, 2006

Study Record Updates

Last Update Posted (Estimate)

November 22, 2007

Last Update Submitted That Met QC Criteria

November 21, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP06-HM/FIBROME

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe