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肝脏 MR 中造影剂检测肝转移的比较

2026年8月31日 更新者:University of Colorado, Denver

与使用钆塞酸二钠的肝脏 MR 相比,使用简化的钆贝酸二葡胺肝胆期方案评估肝脏 MR 以检测肝转移

If an abbreviated hepatobiliary phase (HBP) protocol liver MR with gadobenate dimeglumine is shown clinically comparable to standard of care liver MR with gadoxetate disodium for detecting hepatic metastasis from colorectal cancer, its use will save time, cost, and patients' effort.

研究概览

详细说明

The goal is to:

  • Estimate and compare the diagnostic performance, including sensitivity, specificity, positive/negative predictive value, and area under the receiver operating characteristics (AUROC), of abbreviated protocol liver magnetic resonance (MR) with hepatobiliary phase (HBP) using gadobenate dimeglumine for detecting liver metastases, with 1) abbreviated protocol liver MR with HBP using gadoxetate disodium, 2) standard of care complete protocol liver MR using gadoxetate disodium, and 3) complete protocol liver MR using gadobenate dimeglumine.
  • Estimate and compare quantitative measures of HBP images (liver enhancement ratio, lesion contrast to noise and signal to noise ratios [CNR and SNR]) for both gadobenate dimeglumine and gadoxetate disodium.
  • Qualitatively assess the preference, or lack thereof, of radiologists regarding the images generated by abbreviated protocol liver MR with HBP using gadobenate dimeglumine versus abbreviated protocol liver MR with HBP using gadoxetate disodium.

研究类型

介入性

注册 (实际的)

10

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Colorado
      • Aurora、Colorado、美国、80045
        • University of Colorado Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Colorectal cancer patients
  • Age 18-80 years
  • No prior treatment including surgery
  • Prior imaging with suspected liver metastasis

Exclusion Criteria:

  • Age < 18 years or > 80 years
  • eGFR < 30 ml/min/1.73 m2
  • Previous reaction to gadolinium contrast agents
  • History of claustrophobia or movement disorders likely to impact image quality
  • Non-MR safe implants or metallic foreign bodies

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Gadoxetate disodium exam first, Gadobenate Dimeglumine exam second

The subjects will be randomized into two groups. Both groups will undergo two complete protocol liver magnetic resonance imaging (MRI) for known or suspected colorectal cancer (CRC) metastasis, one exam with gadoxetate disodium and the other exam with gadobenate dimeglumine, within an interval of 3-20 days, but in opposite order, determined randomly.

Gadoxetate disodium MR contrast is now mainly used for the purpose of HBP liver MR imaging to save MR scanner time and total examination time.

其他名称:
  • 原始主义者
  • 亿维斯特

The most commonly used MR contrast agent in abdominal imaging is gadobenate dimeglumine, which has mainly the characteristics of an extracellular agent used for most indications of MR examinations.

其他名称:
  • 多汉斯
实验性的:Gadobenate Dimeglumine exam first, Gadoxetate disodium exam second

The subjects will be randomized into two groups. Both groups will undergo two complete protocol liver MRI for known or suspected CRC metastasis, one exam with gadoxetate disodium and the other exam with gadobenate dimeglumine, within an interval of 3-20 days, but in opposite order, determined randomly.

Gadoxetate disodium MR contrast is now mainly used for the purpose of HBP liver MR imaging to save MR scanner time and total examination time.

其他名称:
  • 原始主义者
  • 亿维斯特

The most commonly used MR contrast agent in abdominal imaging is gadobenate dimeglumine, which has mainly the characteristics of an extracellular agent used for most indications of MR examinations.

其他名称:
  • 多汉斯

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Preference of Radiologists for the Hepatobiliary Phase Images Generated by MultiHance (amHBP) Versus Eovist (aeHBP).
大体时间:1 month

The quality of amHBP and aeHBP images was assessed using ordinal response mixed effect models that included right/left image position as a covariate. For each paired comparison, radiologists indicated their preferred hepatobiliary phase image.

1 month
Quantitative Timing Measures for Hepatobiliary Phase MRI
大体时间:1 month

Measures of timing used to obtain hepatobiliary phase images.

1 month
Estimate and Compare Quantitative Measures of HBP Images (Liver Enhancement Ratio, Lesion Contrast to Noise and Signal to Noise Ratios [CNR and SNR]) for Both Gadobenate Dimeglumine and Gadoxetate Disodium.
大体时间:1 month

A single reader analyzed paired Eovist and MultiHance hepatobiliary phase images (N=10 paired datasets). Quantitative metrics included liver-to-metastasis, liver-to-spleen, liver-to-muscle, and liver-to-blood contrast ratios (CNR's), as well as liver signal-to-noise ratio (SNR). All CNR's were calculated as signal intensity of liver relative to the reference tissue, with liver SNR liver signal/liver noise. Higher contrast ratios and higher SNR values indicate greater liver enhancement and improved lesion conspicuity.

1 month
Estimate and Compare Qualitative Measures of HBP Images for Both Gadobenate Dimeglumine and Gadoxetate Disodium.
大体时间:1 month

A single reader performed a qualitative assessment of Dynamic and Hepatobiliary Phase Image Quality (Likert scale 1-5) for both Eovist and MultiHance Hepatobiliary Phase images (N=10 paired data). Higher scores indicate better image quality.

1 month

次要结果测量

结果测量
措施说明
大体时间
Diagnostic Performance of Gadobenate Dimeglumine
大体时间:1 year

The primary performance diagnostic will be sensitivity, similar to the recently published retrospective study by Canellas et al. (2019). In addition to other diagnostic performance metrics of interest (e.g., specificity, AUROC), lesions will be analyzed descriptively in terms of number of metastases detected and lesion size.

1 year
Compare Sensitivity and Specificity,
大体时间:17 months

The primary analysis will use pathology as the gold standard, if available, but will revert to long term imaging in the absence of pathology. To address the potential impact of this limitation, we will also conduct an exploratory analysis to compare the sensitivity and specificity of the imaging methods by each gold standard.

17 months
Test Validity of Imaging Methods
大体时间:17 months

We will also conduct an exploratory analysis to test the validity of long term imaging as a gold standard against available pathology reports.

17 months
Compare Patient Time Associated With Imaging Method
大体时间:17 months

In addition to analyses for the primary aims, additional analyses will be conducted to examine patient time associated with each imaging method; time metrics can be compared between imaging methods in absolute terms, but also proportionally to sensitivity.

17 months
Compare Cost Associated With Imaging Method
大体时间:17 months

In addition to analyses for the primary aims, additional analyses will be conducted to examine cost associated with each imaging method; cost metrics can be compared between imaging methods in absolute terms, but also proportionally to sensitivity.

17 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Nikhil Madhuripan, MD、University of Colorado, Denver

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年6月22日

初级完成 (实际的)

2025年5月6日

研究完成 (实际的)

2025年5月8日

研究注册日期

首次提交

2021年7月1日

首先提交符合 QC 标准的

2021年7月13日

首次发布 (实际的)

2021年7月22日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年8月31日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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