Safety and Feasibility of Irreversible Electroporation for Early-stage Breast Cancer: a Prospective, Open-Label, Single-Arm, Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Complete ablation rate
研究概览
简要总结
This is a prospective, open-label, single-arm, exploratory clinical trial conducted at our institution to investigate the use of Irreversible Electroporation (IRE) for the treatment of breast cancer.
详细描述
This is a prospective, open-label, single-arm, exploratory clinical trial conducted at our institution to investigate the use of Irreversible Electroporation (IRE) for the treatment of breast cancer. Qualified patients will receive IRE ablation, followed by standard surgical resection. The efficacy and feasibility of IRE will be evaluated through statistical analysis of the outcomes, which will be recorded in accordance with the primary and secondary efficacy endpoints.
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
- •Female, aged 18 years or older.
- •Medically fit for both surgery and general anesthesia, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Treatment-naïve, primary, unifocal breast cancer with a maximum diameter of ≤ 2.0 cm as assessed by MRI.
- •Pathologically confirmed diagnosis of Invasive Ductal Carcinoma (IDC) within 3 months prior to enrollment.
- •Tumor that presents as a well-defined, localized mass and is clearly visualized on both breast ultrasound (for intraoperative guidance) and breast DCE-MRI (for baseline measurement and treatment planning).
- •The subject must be able to understand the purpose of the trial, voluntarily participate, and provide written informed consent.
排除标准
- •Known coagulopathy or bleeding diathesis (defined as a platelet count < 50×10⁹/L or an International Normalized Ratio (INR) > 1.5).
- •Presence of an implanted cardiac pacemaker, defibrillator, or any other active electronic medical device.
- •History of significant cardiac disease, including but not limited to: uncontrolled cardiac arrhythmias or congestive heart failure classified as New York Heart Association (NYHA) Class III or IV.
- •Patients who are pregnant, lactating, or planning a pregnancy during the study period.
- •Known severe allergy or anaphylactic reaction to MRI contrast agents.
- •Known high-risk genetic susceptibility to breast cancer (e.g., BRCA1/2 mutation carrier) associated with an increased risk of ipsilateral breast tumor recurrence following ablation.
- •Presence of distant metastases.
- •Any other medical or psychiatric condition that, in the investigator's judgment, would compromise the patient's safety or compliance with the study protocol.
结局指标
主要结局
Complete ablation rate
时间窗: 1 month
Pathologically confirmed absence of viable tumor cells in the resected tumor bed and margins of the post-IRE surgery specimen.
Technical success rate
时间窗: 1 month
The technical success rate of IRE ablation followed by surgery in treating breast cancer
次要结局
- Incidence of Treatment-Emergent Adverse Events(1 month)
- Pain scores(1 month)
- Imaging analysis(1 month)
- Pain scores(1 month)
- Imaging analysis(1 month)
研究者
Tian'an Jiang
Chief Physician
First Affiliated Hospital of Zhejiang University