Microbubble Contrast Ultrasound and Transient Elastography Imaging of Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Evidence of the presence of angiogenic tumour vasculature in patients diagnosed with DCIS utilizing contrast enhanced ultrasound.
研究概览
简要总结
This is a pilot study designed to investigate new techniques to guide the appropriate diagnosis and treatment of Ductal Carcinoma In-situ (DCIS). The microvascularity and stiffness of the lesion may be prognostic factors that can guide the need for more or less extensive therapy or perhaps only imaging follow-up may be needed.
详细描述
Women who have imaging findings suggestive of DCIS, who are having breast ultrasound and who are candidates for surgery will be eligible. They will receive a contrast-enhanced breast ultrasound after the intravenous injection of a microbubble contrast agent which will show the microvascularity. A subset of women will also have ultrasound elastography performed of the abnormality to evaluate its stiffness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A woman with imaging signs suggesting a diagnosis of DCIS who is scheduled for ultrasound and a biopsy is eligible for the study.
- •At least 18 years of age
排除标准
- •Pregnant or possibly pregnant or breast feeding
- •Unable to provide informed consent
- •Drug or multiple allergies
- •Known cardiac shunts
- •Known cardiac or chronic pulmonary disease
- •Hypersensitivity to perflutren
研究组 & 干预措施
Contrast perfusion and elastography arm
Intravenous injection of microbubble contrast agent and elastography
干预措施: Perflutren lipid microsphere (Drug)
结局指标
主要结局
Evidence of the presence of angiogenic tumour vasculature in patients diagnosed with DCIS utilizing contrast enhanced ultrasound.
时间窗: The participant will be followed up till the results of the biopsy, an expected average of 3 months.
次要结局
- Measurement of transient shear wave elastography .(The participant will be followed up till the results of the biopsy, an expected average of 3 months.)