High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study (Breast Resection By HIFU)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Efficacy of HIFU for the treatment of breast tumors, based on histological criteria
研究概览
简要总结
Monocentric prospective study evaluating the efficacy of High intensity focused ultrasound (HIFU) in breast tumors.
详细描述
Incidence of breast cancer increases with the lifetime of the population, and represents an important socio-economic issue. Diagnosis and treatment are major public health issues. High Instensity Focused Ultrasound (HIFU) is a minimally invasive technique which decreases the risk of post-treatment complications and allows shorter hospitalization times. This technology is also remarkable for the absence of limitation related to the dose delivered, which makes it possible to repeat if necessary and the absence of ionizing radiation both for the treatment itself and for its guidance (MRI).
The main objective is to evaluate the efficacy of HIFU for the treatment of breast tumors, based on histological criteria.
Indication :
Histologically invasive ductal carcinoma, T0, with unifocal or plurifocal lesion, with or without associated microcalcifications, measuring 15 mm maximum on ultrasound and clinical N0.
Course of the study :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Efficacy of HIFU for the treatment of breast tumors, based on histological criteria
时间窗: Day 30
* Complete success: absence of viable invasive tumor cells on histological analysis. * Incomplete success: Partial tumor destruction of the invasive contingent, unhealthy margins due to underestimation of tumor volume before treatment or imperfect targeting of focused ultrasound. Incomplete successes will be considered as failures. The persistence of an in situ quota alone will be considered as success. * Failure: presence of viable invasive tumor cells in the treated area.
次要结局
- Immediate complications of focused ultrasound(Day 30)
- Feasibility of non-invasive pre-surgical identification of the tumor area to be resected (palpation by the surgeon of the focused ultrasound ablation zone)(Day 2, 8)
- Pain (visual analogue scale) experienced by patients during the sedation procedure, until surgery.(Day 0, 2)