NCT00351494

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2006

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

November 22, 2007

Status Verified

November 1, 2007

First QC Date

July 12, 2006

Last Update Submit

November 21, 2007

Conditions

Myoma

Keywords

embolizationcontrast enhanced ultrasoundmyomauterine arterymicrovascularisation

Outcome Measures

Primary Outcomes (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

    Inclusion period and follow-up

Secondary Outcomes (3)

  • 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

Interventions

contrast enhanced ultrasonographyPROCEDURE

Three contrast-enhanced ultrasonography : before embolization, after one day and after 6 months. Abdominal route 2.4 ml sonovue per injection / bolus

embolizationPROCEDURE

Intervention is described in the case report form for each patient

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women candidate for embolization of myomas

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Innovation Technologique-Ultrasons

Tours, 37344, France

RECRUITING

Related Publications (3)

  • Tranquart F, Brunereau L, Cottier JP, Marret H, Gallas S, Lebrun JL, Body G, Herbreteau D, Pourcelot L. Prospective sonographic assessment of uterine artery embolization for the treatment of fibroids. Ultrasound Obstet Gynecol. 2002 Jan;19(1):81-7. doi: 10.1046/j.0960-7692.2001.00535.x.

    PMID: 11851974BACKGROUND

  • Marret H, Cottier JP, Alonso AM, Giraudeau B, Body G, Herbreteau D. Predictive factors for fibroids recurrence after uterine artery embolisation. BJOG. 2005 Apr;112(4):461-5. doi: 10.1111/j.1471-0528.2004.00487.x.

    PMID: 15777445BACKGROUND

  • Marret H, Tranquart F, Sauget S, Alonso AM, Cottier JP, Herbreteau D. Contrast-enhanced sonography during uterine artery embolization for the treatment of leiomyomas. Ultrasound Obstet Gynecol. 2004 Jan;23(1):77-9. doi: 10.1002/uog.944.

    PMID: 14971005BACKGROUND

MeSH Terms

Conditions

Myoma

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Hemostatic TechniquesTherapeuticsTherapeutic Occlusion

Study Officials

  • Henri MARRET, Pr

    Service de Gynécologie Obstétrique CHRU TOURS

    PRINCIPAL INVESTIGATOR

  • François TRANQUART, Pr

    Centre d'Innovation Technologique CHRU TOURS

    STUDY DIRECTOR

Central Study Contacts

Henri MARRET, Pr

CONTACT

(33) 2 47 47 82 59marret@med.univ-tours.fr

Catherine ROUSSEL, ARC

CONTACT

(33) 2 47 47 97 89roussel@med.univ-tours.fr

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 12, 2006

First Posted

July 13, 2006

Study Start

July 1, 2006

Study Completion

June 1, 2009

Last Updated

November 22, 2007

Record last verified: 2007-11

Locations

FR(1)