Radiofrequency Ablation in Breast Tumors in Early Stages
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- MRI post-RFA
研究概览
简要总结
To validate the efficacy and safety of the cool-tip ablation method for breast tumors smaller than 2 cm.
详细描述
A prospective, phase II-III study, which will include a series of cases of 30 patients. The hospitals involved will be Bellvitge University Hospital and Hospital del Mar.
Efficacy was evaluated according magnetic resonance image and biopsy of the breast 1 month after the procedure.
Patients will be followed up over a 2-year period to assess cosmetic results, short and long-term complications and possible recurrences.
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
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infiltrating ductal carcinoma according the biopsy of the breast,
- •Tumor visible by ultrasound, smaller than 2 cm,
- •Located > 1 cm from the chest wall and the skin.
排除标准
- •Personal antecedents of breast cancer
- •Multifocality or intraductal carcinoma
- •Lobular infiltrating carcinoma
- •Neoadjuvant therapy
结局指标
主要结局
MRI post-RFA
时间窗: "1 month"
Magnetic Resonance Image after Radiofrequency ablation to confirmate complete disappearance of tumor contrast enhancement (residual mm).
BAG post-RFA
时间窗: "1 month"
Breast biopsy after Radiofrequency to confirmate absence of viable tumor tissue using NADH, CK18 and CK19 stainings (tumor viability scale: 0, \<25%, 25-50%, 50-75%, \> 75%).
次要结局
- Quality("1 month")
- Adverse Effects("1 month")
研究者
Amparo Garcia-Tejedor
PRINCIPAL INVESTIGATOR
Hospital Universitari de Bellvitge