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Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization

NCT ID: NCT00351494

Last Updated: 2007-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myoma

Keywords

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embolization contrast enhanced ultrasound myoma uterine artery microvascularisation

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type PROCEDURE

embolization

Intervention is described in the case report form for each patient

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Principal Investigators

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Henri MARRET, Pr

Role: PRINCIPAL_INVESTIGATOR

Service de Gynécologie Obstétrique CHRU TOURS

François TRANQUART, Pr

Role: STUDY_DIRECTOR

Centre d'Innovation Technologique CHRU TOURS

Locations

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Centre d'Innovation Technologique-Ultrasons

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Henri MARRET, Pr

Role: CONTACT

Phone: (33) 2 47 47 82 59

Email: [email protected]

Catherine ROUSSEL, ARC

Role: CONTACT

Phone: (33) 2 47 47 97 89

Email: [email protected]

Facility Contacts

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Henri MARRET, Pr

Role: primary

Catherine ROUSSEL, ARC

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 11851974 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15777445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14971005 (View on PubMed)

Other Identifiers

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HP06-HM/FIBROME

Identifier Type: -

Identifier Source: org_study_id