NCT01827969撤回不适用
Feasibility Study of Ablathermy Focused Ultrasound (USF) of Breast Tumors Before Mastectomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Effectiveness of ablathermy
研究概览
简要总结
The treatment consists of tumor ablation by Ablathermy Focused Ultrasound (USF), guided by MRI, performed under local anesthesia and sedation.
详细描述
The treatment consists of tumor ablation by USF, guided by MRI, performed under local anesthesia and sedation. Patients will be operated (mastectomy) from 48 hours after ablation.
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
- •Invasive Breast Carcinoma with histologically confirmed hormone receptor analysis, the grade of the tumor, the expression of Her-
- •Lesion classified T1-T2-T3 unifocal or multifocal with or without associated microcalcifications
- •Lesion recognizable and identifiable in MRI
- •Indication of mastectomy with or without axillary
- •Lesion located more than 10 mm from the skin, the nipple and pectoralis major
- •No cons-indication to MRI (pacemaker)
- •Women whose age is ≥ 18 years
- •If premenopausal patient: patient contraceptives
- •Patient has signed informed consent
- •Affiliation to a social security scheme
排除标准
- •Tumor-TD T4B classified or non-palpable lesion
- •If age <70 years: no indication of adjuvant chemotherapy and neoadjuvant
- •MRI lesions have not been identified, located within 10 mm of the skin and pectoral muscle, greater than 25 mm diameter
- •Inability to hold still in the prone position, arms extended, for 30 minutes
- •Contraindication to MRI
- •Patient deprived of liberty and major subject of a measure of legal protection or unable to consent
- •Patient participating in another interventional clinical trial within 30 days prior to baseline and during the trial.
结局指标
主要结局
Effectiveness of ablathermy
时间窗: 2 years
Effectiveness of ablathermy focused ultrasound breast tumors will be assessed based on histological criteria : the intervention will be considered effective for a participant if there is a destruction of the tumor mass by coagulation necrosis
次要结局
未报告次要终点
研究者
研究点 (2)
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