Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization

Myoma Clinical Trial

Official title:

Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00351494
• Other study ID #: HP06-HM/FIBROME
• Status: Recruiting
• Phase: N/A
• First received: July 12, 2006
• Last updated: November 21, 2007
• Start date: July 2006
• Est. completion date: June 2009

Study information

• Verified date: November 2007
• Source: University Hospital, Tours
• Contact: Henri MARRET, Pr
• Phone: (33) 2 47 47 82 59
• Email: marret[@]med.univ-tours.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Myoma

Intervention

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

Locations

Country	Name	City	State
France	Centre d'Innovation Technologique-Ultrasons	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Accordance between contrast-enhanced imaging and IRM		inclusion period and follow-up
Secondary	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
Secondary	Relationship between the post embolization pain and the vascular change of the fibroma and the myometrium		inclusion period