Feasibility Study of Cavity Radiofrequency Ablation in ex Vivo Mastectomy Breast Tissue
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Ablation Depth
研究概览
简要总结
The purpose of this study is to build a device that will consistently ablate (destroy or remove) cavitary breast tissue after a formal breast cancer resection in order to mimic the tissue that is now irradiated after breast cancer lumpectomy. The device would be easier to handle, perform the ablation in less time and by so ablating this margin would avoid the need in many for reoperation to obtain negative margins and based on preliminary data avoid the need for radiation. This would be especially important in poor and rural patients and would lead to decreased costs of treatment in patients with favorable breast cancer.
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
- •Age greater than or equal to 18 years.
- •Receiving bi-lateral mastectomy due to tumor in the breast, or by choice (prophylactic mastectomy). Only non-cancerous breast tissue will be included in the study.
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Those determined by the study investigator to have mental, physical, or medical conditions that would indicate that they should not participate.
- •Because there is no patient contact with the device no medical contraindications are foreseen.
结局指标
主要结局
Ablation Depth
时间窗: One year
Ablation depth is the extent to which tissue has been completely desiccated from the wall of the cavity. It will be assessed by pathologic analysis using H\&, PCNA, and Ki67 stains. The ablation depth of each slide processed is to be the smallest distance of completely necrotic tissue.
次要结局
未报告次要终点