Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
时间窗: Inclusion period and follow-up
次要结局
- 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)