Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves: time-to-peak, enhancement ratio, washout-time
研究概览
简要总结
This study intends to assess the ability of contrast-enhanced ultrasound in the detection of benign and malignant ovarian masses compared to unenhanced ultrasound.
By using an intravascular contrast agent, this noninvasive and feasible imaging technique will allow the investigators to define specific microcirculation patterns in 100 women with ovarian lesions.
The intravascular contrast agent properties will be compared between benign and malignant adnexal masses.
The final purpose of this ultrasonography is to allow the early detection of tumors and to improve the characterization between benign and malignant lesions.
详细描述
SonoVue (Sulphur hexafluoride microbubbles) is a microbubbles preparation that is stable, resistant to pressure and specifically designed to be used as a contrast agent for ultrasound imaging.
Study design : one contrast-enhanced ultrasonography is proposed before any surgery to patients with ovarian mass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •18 years of age or older
- •Patient with adnexal mass detected by ultrasound
- •Any programmed surgery
排除标准
- •Any contraindication to surgery
- •Injection of another contrast agent within 24 hours before the study examination
- •Pregnancy, breastfeeding
- •Patient known to have a coronary syndrome
- •Unstable angina and myocardial infarction
- •Acute cardiac failure, Class III/IV cardiac failure
- •Severe rhythm disorders
- •Acute endocarditis
- •Prosthetic valves
- •Patient previously having received an investigational drug within 30 days prior to admission into this study
结局指标
主要结局
From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves: time-to-peak, enhancement ratio, washout-time
时间窗: inclusion period
次要结局
- Histology assessments: microvessel density assessments and histological diagnosis(inclusion period)