Study of Perfusion and Diffusion Magnetic Resonance Imaging, and Phosphorylation of Circulation Endothelial Cells to Determine Anti-angiogenic Effect in Patients With Colorectal Liver Metastasis in Chemotherapeutic Regimens Including Avastin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- MR perfusion parameter
研究概览
简要总结
The purpose of our study is to establish the accuracy of the perfusion MRI parameters and the availability of the VEGFR2 signaling assay using phosphospecific flow cytometry in predicting the response of liver metastasis from colorectal cancer to treatment with antiangiogenic agent.
详细描述
The purpose of our study is to establish the accuracy of the perfusion MRI parameters and the availability of the VEGFR2 signaling assay using phosphospecific flow cytometry in predicting the response of liver metastasis from colorectal cancer to treatment with antiangiogenic agent.
IRB approval will be obtained to enroll 60 naïve patients (30 patients who will get antiangiogenic agent (Avastin) combined chemotherapy and 30 patients who will get chemotherapy without antiangiogenic agent) with liver metastasis from colorectal cancer. MRI and blood test (VEGFR2 signaling assay) will be undergoing at three time points in the patients with Avastin chemotherapy; at baseline (pretreatment), 3 days after Avastin alone treatment, 3 days after Avastin combined chemotherapy (about 10 days after initial Avastin alone treatment). MRI and blood test (VEGFR2 signaling assay) will be undergoing at two time points in the patients who will get chemotherapy without antiangiogenic agent; at baseline (pretreatment), 3 days after chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have single or multiple liver metastasis from colorectal cancer
- •Patients willing to undergo the study procedure
- •Patients who are fully informed about the study and have signed the informed consent form
- •60 patients (30 patients who will get antiangiogenic agent(Avastin) combined chemotherapy and 30 patients who will get chemotherapy without antiangiogenic agent)
排除标准
- •Patients (men or women) under 20 years of age
- •Patients who have previously entered this study
- •Patients who have received or will receive any investigational drug 48 hours before injection of the study drug or during study participation
- •Women who are pregnant, lactating or who are of childbearing potential and have not had a negative pregnancy test at baseline visit
- •Patients not eligible to contrast media injection according to product labeling
- •Patients with a contraindication for MRI or CT
- •Patients with impaired renal function (e.g. acute renal failure) or patients on dialysis
结局指标
主要结局
MR perfusion parameter
时间窗: 3 days after administrating avastin
MR perfusion parameter(Ktrans, Kep, Ve)
次要结局
- diffusion parameter(3 days after an anti-cancer medicine)