Contrast-enhanced Ultrasound in Neoadjuvant Chemotherapy of Breast Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tumor size reduction (1)
研究概览
简要总结
Effect of the contrast-enhanced diagnostic ultrasound during neoadjuvant chemotherapy of breast cancer on the achieved tumor size reduction and tolerability of chemotherapy
详细描述
The 5-year survival rate of breast cancer patients is decreasing in the advanced, metastatic stage from 99% to 26%. Therefore an optimization of the therapy of advanced breast cancer is urgently needed.
To increase the echogenicity of the blood in the ultrasound, microbubbles were developed working as stable, biocompatible contrast agent in ultrasound. Such a clinically approved ultrasound contrast agent is SonoVue® (Bracco International B.V., Amsterdam). SonoVue® is approved by the European Medicines Agency (EMA) (approval number EU/1/01/177/002) for the visualization of focal vascularization lesions of the liver and breast within Doppler sonography and is applied in breast cancer patients primarily for the purpose of diagnosis as well as to evaluate the response to the neoadjuvant used chemotherapy.
Animal studies using the contrast enhanced ultrasound have shown that the administration of this contrast agent increases the penetration and accumulation of drugs in the tumor as well as the permeability of the blood-brain barrier resulting in a precise and effective drug distribution. In the tumor animal model it could be shown that a combined treatment with chemotherapy and contrast enhanced ultrasound results in a decreased tumor growth and a prolonged survival. Patients with inoperable pancreatic cancer showed a reduced tumor growth and better tolerability of chemotherapy when administrating the contrast enhanced diagnostic ultrasound during palliative chemotherapy. This could be due to the better tumor response, but also due to the more targeted chemotherapy distribution.
The purpose of this study is to examine whether the use of the contrast enhanced diagnostic ultrasound during neoadjuvant chemotherapy results in an increased tumor regression in comparison to native ultrasound. It is an Investigator Initiated Trial and is funded by internal means.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •written informed consent
- •age > 18 yrs
- •histologically confirmed primary breast cancer including all intrinsic subtypes
- •treatment with neoadjuvant chemotherapy
- •persons who are legally competent and mentally able to follow the instructions of the study team
排除标准
- •hypersensitivity / allergy to sulfur hexafluoride, Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol-sodium, palmitic acid
- •right-left shunt,
- •severe pulmonary hypertension (pulmonary arterial pressure > 90 mmHg)
- •uncontrolled systemic hypertension
- •acute respiratory distress syndrome
- •pregnancy
- •commitment of the patient to any resident institution by order of any court or authority
- •expectation of missing compliance
- •alcohol or drug abuse
- •patients who are in a relationship of dependence or in a working relationship to the sponsor, the investigator or his representative
研究组 & 干预措施
A
Application and measurement of tumor size using contrast agent-enhanced diagnostic and therapy supporting (with SonoVue®) ultrasound
干预措施: SonoVue (Drug)
结局指标
主要结局
Tumor size reduction (1)
时间窗: 18 / 24 weeks
pCR (pathohistological complete remission)
Tumor size reduction (2)
时间窗: 18 / 24 weeks
cCR (clinical complete remission)
Tumor size reduction (3)
时间窗: 18 / 24 weeks
measured by ultrasound (% reduction in therapy)
次要结局
- proliferation rate of the tumor cells(18 / 24 weeks)
- narrowing the invasion front of the tumors(18 / 24 weeks)
- macrophage density in the tumor(18 / 24 weeks)
- vascularization of the tumor(18 / 24 weeks)
- tolerability of chemotherapy(18 / 24 weeks)
研究者
Elmar Stickeler
Univ.-Prof. Dr. med.
RWTH Aachen University