Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- The rate of success of cryoablation procedure
研究概览
简要总结
The primary objective of this monocentric and feasibility study is to review the efficacy of cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with lumpectomy indication.
The efficacy is defined by the rate of success of cryotherapy procedures. For each one of those evaluated process, an success will be defined on the tumor sample of lumpectomy by the absence of viable tumour cells.
On the basis of our expertise, it seems interesting to propose this experimental procedure to patients as described above.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non inflammatory unilateral and unifocal breast cancer with indication of lumpectomy
- •Menopausal women with age > 55 years
- •Tumor size <= 15 mm by ultrasonography
- •Histological confirmation (by biopsy) of invasive ductal carcinoma with SBR (Scarff-Bloom-Richardson) grade (modified by Ellis & Elston) 1 or 2; hormone receptors positive (Estrogen Receptor and/or Progesterone Receptor) and negative Human epidermal growth factor receptor (HER2)
- •Good lesion boundary with ultrasonography and MRI
- •Minimal distance of 5 mm between the skin and the tumor
- •Performance Status 0-1
- •Ability to understand and willingness to sign a written informed consent document
- •Covered by a medical insurance
- •Signed informed consent
排除标准
- •Invasive lobular carcinoma
- •Tumor with retro-nipple location
- •Extended microcalcifications (> 15 mm) with mammography
- •Xylocaine allergy
- •Patient deprived of freedom
研究组 & 干预措施
Cryoablation
Cryoablation of the tumor followed by a lumpectomy as practiced in standard care
干预措施: Cryoablation (Device)
结局指标
主要结局
The rate of success of cryoablation procedure
时间窗: 45 days after cryoablation
percentage of viable cells in the piece of lumpectomy
次要结局
未报告次要终点