NCT01422629已完成不适用
High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma: a Feasibility Study. A Multicentric, Open, Uncontrolled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Theraclion
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- HIFU induced tissue necrosis assessed by histology of excised gland or reduction volume of fibroadenoma
研究概览
简要总结
This study is a multicentre, open, uncontrolled trial for the observation of histological changes in breast fibroadenoma following high intensity focused ultrasound (HIFU).
This study will be conducted in France in 20 patients with breast fibroadenoma with indication for a surgical resection. The patient will receive an HIFU treatment and 6 months after treatment, the need of the surgery is evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Diagnosis of breast fibroadenoma based on:Clinical examination, Ultrasound image and mammogram for women older than 35 years, and histology
- •Fibroadenoma size superior at 1 cm at its largest dimension (measured by Ultrasound)
排除标准
- •Patient pregnant or lactating
- •Microcalcifications within the lesion at the mammogram.
- •History of breast cancer or history of laser or radiation therapy to the target breast
- •Breast implant in the target breast.
- •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
HIFU induced tissue necrosis assessed by histology of excised gland or reduction volume of fibroadenoma
时间窗: 6 months after HIFU treatment
次要结局
- - Pain score during the HIFU treatment evaluated by the Visual Analog Scale.(at treatment)
- Percentage of patients with Adverse events(at 12 months follow-up)
- Volume reduction of the fibroadenoma(12 months after HIFU treatment)
研究者
研究点 (4)
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