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临床试验/NCT02177045
NCT02177045Unknown不适用

Breast Lesions Characterization on Contrast Enhanced Ultrasound With Histopathological Correlation

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Tumor vascularization

研究概览

简要总结

Breast lesions are a common condition, diagnosed by imaging and palpation. In order to reduce the number of biopsies performed to the definitive diagnosis of a breast lesion, an imaging method with a high degree of accuracy is needed. Ultrasound imaging with microbubbles contrast media allows the diagnosis of vascularization of the lesion, according to timing. Our hypothesis is that a highly vascularized lesion that enhances in an early timing is most likely to represent a malignant lesion and thus, deserves biopsy for a definitive diagnosis. Females over 18 years age, with a focal lesion in breast will be suitable to perform this examination.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female with a diagnosed breast focal lesion

排除标准

  • Allergic conditions to contrast media,
  • R-L shunt

研究组 & 干预措施

Microbubbles contrast media for US

Experimental

Sonovue, Bracco, microbubbles contrast media

干预措施: Sonovue, Bracco (Drug)

结局指标

主要结局

Tumor vascularization

时间窗: one year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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