Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization - Full Text View

Sponsored by:	University Hospital, Tours
Information provided by:	University Hospital, Tours
ClinicalTrials.gov Identifier:	NCT00351494

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

MedlinePlus related topics: Ultrasound

Drug Information available for: Sulfur hexafluoride

U.S. FDA Resources

Study Type:	Observational
Study Design:	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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

Intervention Details:

Three contrast-enhanced ultrasonography : before embolization, after one day and after 6 months.

Abdominal route 2.4 ml sonovue per injection / bolus

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

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:

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.

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.

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.

Study ID Numbers:	HP06-HM/FIBROME
Study First Received:	July 12, 2006
Last Updated:	November 21, 2007
ClinicalTrials.gov Identifier:	NCT00351494
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Tours:

embolization
contrast enhanced ultrasound
myoma
uterine artery
microvascularisation

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Myoma

Additional relevant MeSH terms:

Neoplasms, Muscle Tissue
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009