A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- From contrast-enhanced ultrasound: Time-intensity curves obtained with SonoVue will help the investigators in differentiation of lesions based on different enhancements.
研究概览
简要总结
Ultrasound is a well-established imaging modality for the evaluation of breast disease.
The investigators' objective is to characterise the properties of an intravascular ultrasonographic contrast agent SonoVue (sulphur hexafluoride microbubbles) to improve the diagnostic value of the ultrasound examination in patients with different breast lesions.
The final purpose of this ultrasonography is to allow the early detection of tumors and to improve the differentiation between benign and malignant lesions.
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.
Contrast-enhanced ultrasound could provide a non-invasive technique to evaluate the morphology of breast tumour vascularity.
详细描述
The main objective of the study is to evaluate the efficacy of SonoVue® to detect breast lesions and define specific microcirculation patterns in patients with four different type of breast lesions (enlarging fibroadenoma, suspect malignant nodules, microcalcification and large malignant nodules) in comparison with pathological specimens in terms of histology diagnosis and microvessel density evaluation.
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
- •Woman presenting with: enlarging fibroadenoma (less than 2 cm in diameter or woman over 40 years old with fibroadenoma less than 2 cm in diameter) or suspect malignant nodule (less than 2 cm in diameter) or a cluster of microcalcification or a malignant nodule (size greater than 3 cm) diagnosed with mammography and/or MRI and/or United States (US) examination performed within 1 month before the study.
- •Woman scheduled for biopsy or surgery within 1 month from the examination.
排除标准
- •Patients who have already performed a biopsy on the lesion during investigation
- •Any contraindication to perform a contrast-enhanced MRI examination for the patients presenting with a malignant nodule (size greater than 3 cm)
- •Patients previously entered in this study or having received an investigational drug within 30 days prior to admission to this study
- •Patients with any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data or of achieving the study objectives (drug dependence, psychiatric disorders, dementia or other reasons)
- •Pregnant or nursing female
- •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
结局指标
主要结局
From contrast-enhanced ultrasound: Time-intensity curves obtained with SonoVue will help the investigators in differentiation of lesions based on different enhancements.
时间窗: Inclusion period
次要结局
- Histology assessments: Microvessel density assessments to evaluate the total amount of microcirculation and the neoangiogenesis microcirculation present in the samples(inclusion period)
- Off-line time-intensity curves from contrast-enhanced magnetic resonance imaging (MRI) images (malignant nodule greater than 3 cm in diameter only)(inclusion period)