Examinations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Tumor response
研究概览
简要总结
The purpose of this study is to see if the investigators can do some tests on tissue from the area of the ablation. The investigators want to know if a test can help predict whether the ablation worked.
The treated tumor is normally evaluated with CT. The CT shows signs of treated tumor(s) in the area treated by ablation. However, cancer cells may begin to grow in or near the treated area. The CT scan cannot tell us if the cells are new cancer cells or if they are healthy liver cells that just look different because of the ablation. The test the investigators will study should be able to tell us the difference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
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
- •Patients with diagnosed with secondary hepatic malignancy;
- •Patients with confined liver disease or stable limited extrahepatic disease;
- •Lesions of 5cm or less in maximum diameter;
- •Patients who are not surgical candidates or refuse to undergo surgery and choose any percutaneous ablation as an alternative treatment option.
- •INR<1.5 *for patients on Coumadin general clinical guidelines for IR ablation will be followed.
- •Platelet count > or = to 50,000
排除标准
- •Patients < 18
- •Less than 5 mm distance of the tumor margin from a major vessel >7mm in diameter)**
- •Less than 5 mm distance to a structure (GI or biliary tract), that cannot be protected from**
- •the ablation injury with technical modifications such as hydro or air dissection.
- •INR > 1.5 that cannot be corrected with fresh frozen Plasma*
- •Platelet count of <50,000 that cannot be corrected with transfusion.
- •Patient with more than 3 tumors treated with any percutaneous ablation
- •Patients with more than 5 sites of extrahepatic disease (including nodes and pulmonary nodules)
- •for patients on Coumadin general clinical guidelines for IR ablation will be followed **This will not be considered an exclusion criteria when IRE or Microwave is used.
- •This will not be considered exclusion when IRE is used
结局指标
主要结局
Tumor response
时间窗: 3 years
will be measured according to EASL and RECIST. In the case of differences between these criteria, the EASL criteria will be used for clinical judgment and decisions.Tumor response will be determined at the discretion of the Principal Investigator in the case of overlapping ablation zones or lesions seen only in PET.
次要结局
- Duration of treatment response(3 years)