Irreversible Electroporation Ablation for Colorectal Metastases to the Lung
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 7
- 主要终点
- The Frequency of Adverse Events
研究概览
简要总结
The investigators are investigating the use of a new cancer treatment called Irreversible Electroporation (IRE). This treatment delivers electrical energy between two needles placed in a cancer. The electrical energy causes cells to die. While this has been used in patients for different applications, the investigators are trying to understand how safe and well it works in colon cancer that has spread to the lung. Once the irreversible electroporation procedure is completed during the operation, the surgeon will then remove the cancer according to standard procedure. As part of the study, they will be measuring safety of the electrical energy delivered and will be reviewing the resected specimen under the microscope.
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
- •Diagnosed Colorectal cancer with oligometastatic colorectal cancer in the lung
- •Lung lesion size is greater than 1 cm
- •Patient will undergo surgical resection as per consultation with their thoracic surgeon and medical oncologist
- •Patient is cleared to undergo paralytic anesthesia.
- •Patients 18 years old and older
排除标准
- •Patients with history of cardiac dysrhythmia
- •Known heart failure (EF < 40%)
- •Pacemaker/defibrillator
- •Patient's with any metallic cardiac implant
- •Patient on anti-coagulation therapy and are unable to stop therapy for the perioperative period
- •Women who are pregnant and/or nursing
研究组 & 干预措施
IRE procedure
The IRE procedure will be performed in the operating room at the time of scheduled clinical resection of colorectal lung metastases by the surgeon with guidance from the Interventional Radiologist.
干预措施: Irreversible Electroporation Ablation (Device)
结局指标
主要结局
The Frequency of Adverse Events
时间窗: 2 years
Safety will be measured by using the NCI Common Terminology Criteria for Adverse Events (CTCAE v4.0). The goal of this study is to establish safety. If there are 3 or more grade 3 or higher device related AEs, then we will stop the study.
次要结局
未报告次要终点