NCT01331954Unknown不适用
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): a Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Theraclion
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Reduction of breast fibroadenoma volume at ultrasonography
研究概览
简要总结
Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •One breast fibroadenoma with diagnosis based on:
- •Clinical examination
- •Ultrasound image
- •For women older than 35 years: mammogram with BI-RADS score < 3
- •Histologic confirmation by two independent readers
- •Fibroadenoma size between 1 cm and 3 cm at its largest dimension (measured by ultrasound)
排除标准
- •Patient pregnant or lactating
- •Bi-RADS score > 2 at the mammogram, or microcalcifications within the lesion.
- •History of breast cancer or history of laser or radiation therapy to the target breast
- •Breast implants
- •Breast cyst
- •Fibroadenoma not clearly visible on the ultrasound images (in B mode)
- •Patient participating in other trials using drugs or devices
结局指标
主要结局
Reduction of breast fibroadenoma volume at ultrasonography
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (2)
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