Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Ability of cryoablation to achieve complete ablation of DCIS
研究概览
简要总结
Cryoablation or tumor freezing is a percutaneous, office-based procedure that is emerging as a minimally invasive, cost-effective alternative to surgery that is currently being evaluated in clinical trials for the management of for early-stage invasive breast cancer. The investigator will also evaluate the potential of cryoablation as a minimally invasive alternative to surgery for small areas of DCIS by examining its ability to achieve complete ablation of DCIS within the targeted cryoablation zone of necrosis.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DCIS spanning 2 cm or less based on its radiographic appearance by mammography and/or breast contrast-enhanced MRI
- •Diagnosis of DCIS by minimally invasive needle biopsy
- •No prior history of DCIS or invasive breast cancer in the same breast
- •No history of surgical biopsy and/or lumpectomy for diagnosis/treatment in the same breast
- •Adequate breast volume and skin clearance to permit cryoablation as assessed by Dr. Holmes. This excludes male and females with breasts too small to allow safe cryoablation
- •Non-pregnant, non-lactating, and no history of pregnancy within the preceding 6 months
- •No history of breast radiation in the same breast
排除标准
- 未提供
结局指标
主要结局
Ability of cryoablation to achieve complete ablation of DCIS
时间窗: 6 months
Number of participants to achieve completeness of ablation by measuring the percentage of subjects with no residual DCIS or invasive cancer within the zero of necrosis assessed in the post-cryoablation core biopsy obtained 6 months post-cryoablation.
次要结局
- Recurrence rate(5 years)
研究者
Dennis Holmes
Principal Investigator
Glendale Adventist Medical Center d/b/a Adventist Health Glendale