Imaging Tissue Motion Using MR Displacement Encoding With Stimulated Echo (DENSE): Detection of Early Chemotherapy Related Liver Injury Prior to Resection of Colorectal Liver Metastases
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Magnetic Resonance Displacement Encoding with Stimulated Echo (MR DENSE) imaging data of patients treated with chemotherapy prior to resection of metastases to explore its utility in detecting sinusoidal liver injury.
研究概览
简要总结
This trial studies how well a magnetic resonance imaging technique called Displacement Encoding with Stimulated Echo (DENSE) works in detecting chemotherapy-related liver injury in patients with colorectal cancer that has spread to the liver and can be removed by surgery. Researchers want to learn if the DENSE technique improves the standard MRI method.
详细描述
PRIMARY OBJECTIVE:
I. This is an exploratory study to collect Magnetic Resonance Displacement Encoding with Stimulated Echo (MR DENSE) imaging data of patients treated with chemotherapy prior to resection of metastases to explore its utility in detecting sinusoidal liver injury.
SECONDARY OBJECTIVES:
I. Estimate sensitivity of MR DENSE (determine degree of 2 dimensional [2D] vector displacement with cardiac cycle and variability of measurements with cardiac ventricle contraction).
II. Determine detection of sinusoidal injury (sinusoidal fibrosis, necrosis of pericentral hepatocytes, narrowing and fibrosis of central veins) on biopsy with non-alignment of 2D point vectors (horizontal and vertical direction) from neighboring/immediate adjacent points on MR DENSE imaging.
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
- 是
入选标准
- •Patients treated with neoadjuvant chemotherapy and scheduled for hepatectomy, per standard of care at our institution, and meet criteria for hepatectomy.
- •No contraindications to MRI (such implanted ferromagnetic or pump devices, metallic fragments in eye), as indicated on our departmental MRI screening form.
- •Patient who is able to undergo informed consent.
- •Men and non-pregnant women.
- •Metastatic disease limited to liver.
- •Metastases involving no more than 6 liver segments.
- •No radiographic evidence of involvement of the hepatic artery, major bile ducts, main portal vein, celiac/para aortic lymph nodes.
排除标准
- •Contraindication to MRI.
- •Inability to comply with study and/or follow-up procedures.
- •Unable to provide informed consent.
- •Presence of extrahepatic metastatic disease.
- •Metastases involving more than 6 liver segments.
- •Radiographic evidence of involvement of the hepatic artery, major bile ducts, main portal vein, celiac/para aortic lymph nodes.
- •Pregnant women.
结局指标
主要结局
Magnetic Resonance Displacement Encoding with Stimulated Echo (MR DENSE) imaging data of patients treated with chemotherapy prior to resection of metastases to explore its utility in detecting sinusoidal liver injury.
时间窗: through study completion, an average of a year.
次要结局
未报告次要终点