Contrast-Enhanced Ultrasound and Neoadjuvant Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves
研究概览
简要总结
This study intends to assess the ability of contrast-enhanced ultrasound to make the efficacy of chemotherapy in breast cancer precise.
This real-time noninvasive and feasible imaging technique allows us, the investigators at University Hospital Tours, to evaluate early vascular changes of breast tumors during treatment. These vascular changes may precede long-term tumoral regression. Imaging of primary breast lesions may be of value in the prediction of late treatment response.
An ultrasound will be performed before the initiation, and after the second and the last dose of chemotherapy.
To investigate the changes occurring in the vascularization of tumors, we will use an intravascular ultrasound contrast agent SonoVue (sulphur hexafluoride microbubbles).
This agent is a microbubbles preparation that is stable, resistant to pressure, and specifically designed to be used as a contrast agent for ultrasound imaging of angiogenesis.
详细描述
The main objective of the study is to evaluate the early vascular changes of the tumor during neoadjuvant chemotherapy compared to the clinical or MRI or histological response.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast tumor (size equal to or greater than 3 cm.). Patients with diagnosis of benign breast tumor based on biopsy will be excluded from the study after the first ultrasound examination.
- •Neoadjuvant chemotherapy is programmed when an epithelial carcinoma is diagnosed by histology.
- •Performance status = 0, 1 or 2
- •No previous surgery or local radiotherapy
排除标准
- •Psychiatric disorders
- •Vital threat due to other disease
- •Vital prognosis < 3 months
- •Biopsy of the lesion performed within 1 month before the ultrasonography
- •Patient known to have a coronary syndrome
- •Unstable angina and myocardial infarction
- •Acute cardiac failure, Class III/IV cardiac failure
- •Several arrhythmias
- •Acute endocarditis
- •Prosthetic valves
结局指标
主要结局
From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves
次要结局
未报告次要终点