A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 99
- 试验地点
- 31
- 主要终点
- Rate of Complete Tumor Ablation
研究概览
简要总结
This phase II trial is studying how well cryoablation therapy works in treating patients with invasive ductal breast cancer. Cryoablation kills tumor cells by freezing them. This may be an effective treatment for patients with invasive ductal breast cancer.
详细描述
This is a phase II non-randomized exploratory study. All fully eligible and registered patients will undergo imaging by mammography, ultrasound, and breast MRI. Patients will then undergo complete surgical resection of the primary tumor. The primary and secondary objectives of the study are described below.
OBJECTIVES:
Primary
- To determine the rate of complete tumor ablation in patients treated with cryoablation, with complete tumor ablation defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion
Secondary
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
- All
- 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
Rate of Complete Tumor Ablation
时间窗: Up to 14 days post surgery
The primary endpoint for this study is the rate of complete ablation. Complete ablation is defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion. The rate (percentage) will be computed as the number of patient lesions with complete tumor ablation divided by the total number of eligible patient lesions. This rate will be estimated by the binomial point estimate (number of patients with no pathological evidence of residual disease in the targeted lesion after ablation divided by the number of eligible patients) and a one-sided 90% binomial confidence interval (interval with a lower bound).
次要结局
- Negative Predictive Value of MRI(Up to 14 days post cryoablation)
- Adverse Events(Up to 14 days post surgery)
- Pain Assessment(Up to 14 days post surgery)