Clinical trial NCT00351494: Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization
Official title: Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myoma
Keywords: embolization
contrast enhanced ultrasound
myoma
uterine artery
microvascularisation
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2006-07-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women candidate for embolization of myomas

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.

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 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

Primary outcomes:
measure: 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
timeFrame: Inclusion period and follow-up
Secondary outcomes:
measure: Accordance between contrast-enhanced imaging and IRM
timeFrame: inclusion period and follow-up
measure: Accordance between early vascular patterns due to embolization of the fibroma and the success of the technique which is evaluated after 6 month
timeFrame: inclusion period and follow-up
measure: Relationship between the post embolization pain and the vascular change of the fibroma and the myometrium
timeFrame: inclusion period
Other outcomes:
Locations:
city: Tours
country: France
facility: Centre d'Innovation Technologique-Ultrasons
Study officials:
affiliation: Service de Gynécologie Obstétrique CHRU TOURS
name: Henri MARRET, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre d'Innovation Technologique CHRU TOURS
name: François TRANQUART, Pr
role: STUDY_DIRECTOR
References:
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. doi: 10.1046/j.0960-7692.2001.00535.x.
citation: 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.
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. doi: 10.1002/uog.944.