Clinical Trial Optimizing Tumor Ablation for Liver Metastases: Rapid Tissue Analysis Allowing for Immediate Retreatment; Metabolic Imaging Biomarker Validation; and Predictive Genetic Signatures
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Tumor response
研究概览
简要总结
This study will see whether collecting and analyzing needle biopsy samples from cancer liver metastases after a tumor ablation procedure will be able to identify cancer cells that are still alive. The results of these biopsies could help determine the next treatment for your cancer, but the biopsies could cause side effects.
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
- 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
- •Diagnosis of liver metastases from various primary tumors
- •Confined liver disease or limited extrahepatic disease stable/controlled for at least 4 months (extrahepatic disease amenable to treatment is allowed)
- •Lesions of ≤3 cm in maximum diameter
- •At least one FDG-avid lesion to be treated***
- •INR < 1.5*
- •Platelet count ≥ 50,000
排除标准
- •Age < 18
- •Less than 5 mm distance to a structure (GI or biliary tract), that cannot be protected from 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
- •More than 3 tumors in the liver
- •More than 5 tumors of extrahepatic disease (including mediastinal nodes and pulmonary nodules, abdominal or other lymph nodes, and bone metastasis)
- •Presence of any peritoneal Carcinomatosis
- •For patients on Coumadin, general clinical guidelines for IR ablation will be followed.
- •For patients with no FDG-PET avid tumors aim 2 of the protocol will not be assessed
研究组 & 干预措施
Patients with Liver Metastases
The standard of care tumor ablation procedure, post-ablation biopsies and pre- and post-ablation PET scans. If the PET scan is positive (shows areas of cancer in the treated metastases), study participants will undergo additional needle biopsies of the positive areas on the scan. If the biopsies show areas of cancer cells that are still alive, the participants will be immediately retreated with a second ablation procedure.
干预措施: [18-F]- FDG - PET (Diagnostic Test)
Patients with Liver Metastases
The standard of care tumor ablation procedure, post-ablation biopsies and pre- and post-ablation PET scans. If the PET scan is positive (shows areas of cancer in the treated metastases), study participants will undergo additional needle biopsies of the positive areas on the scan. If the biopsies show areas of cancer cells that are still alive, the participants will be immediately retreated with a second ablation procedure.
干预措施: Tumor ablation (TA) (Procedure)
Patients with Liver Metastases
The standard of care tumor ablation procedure, post-ablation biopsies and pre- and post-ablation PET scans. If the PET scan is positive (shows areas of cancer in the treated metastases), study participants will undergo additional needle biopsies of the positive areas on the scan. If the biopsies show areas of cancer cells that are still alive, the participants will be immediately retreated with a second ablation procedure.
干预措施: PET/CT Scan (Diagnostic Test)
结局指标
主要结局
Tumor response
时间窗: 2 years
will be measured according to RECIST and PERCIST 1.0. The first CT and PET scan taken after ablation will be considered the new baseline for subsequent comparisons and measurements.
次要结局
未报告次要终点