跳至主要内容
临床试验/NCT02652663
NCT02652663Unknown不适用

Liver MRI for Colorectal Cancer Liver Metastasis: Comparative Effectiveness Research for the Choice of Contrast Agents

Yonsei University0 个研究点目标入组 500 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
主要终点
Disease free survival

研究概览

简要总结

Magnetic resonance imaging (MRI) has been widely used for problem-solving tool in the evaluation of hepatic lesions, and it has been shown to have better sensitivity than CT for detection of colorectal liver metastases, especially for lesions which are smaller than 1 cm. After introduction of a liver-specific hepatobiliary MR contrast agent, gadoxetic acid, gadoxetic acid-enhanced MRI (Gd-EOB-MRI) has been increasingly used for evaluation of liver lesion including CRLM. However, compared to conventional MRI with extracellular contrast agent (ECA-MRI), Gd-EOB-MRI has different pharmacodynamic characteristics, and is more expensive due to higher cost of gadoxetic acid and needs longer scan time to obtain hepatobiliary phase which is generally acquired 15 to 20 minutes after contrast injection. The purpose of this study was to compare the clinical outcome and diagnostic performance of Gd-EOB-MRI and ECA-MRI for evaluation of focal hepatic lesion in newly diagnosed colorectal cancer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with surgically proven colorectal adenocarcinoma
  • patients who underwent abdominopelvic CT and liver MRI for initial staging before any treatment
  • no past or concurrent malignancy other than colorectal adenocarcinoma.

排除标准

  • precontrast abdominopelvic CT
  • precontrast liver MRI
  • liver MRI using contrast other than extracellular agent or gadoxetic acid
  • the interval between CT and liver MRI was longer than 4 weeks
  • patients who had suspected multiple hepatic metastases (> 10) on CT
  • distant metastasis other than liver and
  • unavailable reference standard of their hepatic lesions with no pathologic confirmation or follow up imaging.

结局指标

主要结局

Disease free survival

时间窗: up to 120 months

From date of curative hepatic surgery until the date of first documented tumor recurrence or date of death from disease-related cause

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

相似试验