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Multiparametric MR for Rapid Imaging Assessment of the Liver (RIAL)

2012年3月2日 更新者:University of Oxford

Rapid Imaging Assessment of the Liver Using Multiparametric Magnetic Resonance

The RIAL study aims to investigate whether non-invasive measurement of liver fat, iron content and fibrosis are as accurate as liver biopsy specimens in determining if patients have non-alcoholic fatty liver disease (NAFLD) or steatohepatitis (NASH), or other suspected liver disease.

Currently, the gold-standard for the diagnosis and staging of liver disease is a liver biopsy.

In this study, consecutive patients will be offered a multiparametric MR scan to assess their liver while they await a liver biopsy.

Study time-frame: The scan will be performed in the 6-week period before their biopsy, and results will be compared to biopsy findings. results will be presented at the end of the study when MR data outcomes are compared to gold-standard biopsy dat. Participants will only have to attend one study visit to participate - there will be no patient follow-up.

研究概览

地位

未知

详细说明

Obesity per se as a cause of liver dysfunction and failure has been well studied. However, although it is a very common disease, at present the only reliable way to diagnose it is with percutaneous liver biopsy. This is painful and not without risk, as the liver is a highly vascular organ. Even with ultrasound guidance, it is still a diagnostic test that is underused as it carries a 1:1000 risk of serious adverse events (eg bleeding, infection, bowel perforation) because it is invasive. Moreover, the patients requiring the test often have impaired clotting of their blood due to liver dysfunction, and so are at higher risk of bleeding, and need to be observed in hospital for a few hours after the procedure. This adds to the cost of the procedure. As a result of these factors, liver biopsy is not used in all patients for whom NAFLD, NASH or other liver disease are suspected, unless the patients have clinically moderate to severe disease.

With the increasing prevalence of obesity in the community, NASH and NAFLD are becoming increasingly common, and there is a need for a reliable, feasible and cost-effective non-invasive diagnostic tool for these conditions. Moreover, they often coexist with other liver diseases (eg tumours, or autoimmune liver disease). There are approximately 1.5million UK adults with mild to moderate liver disease which, at present, cannot be ascertained non-invasively.

Developments in magnetic resonance medicine may allow us to accurately diagnose liver fibrosis, using the amount of extracellular fluid (ECF) as a biomarker for fibrosis. T1 mapping of the liver can reliably show differences in ECF content and thereby allow quantification of the degree of liver fibrosis. In conjunction with MR spectroscopy and T2* mapping for concurrent interpretation of lipid and iron content, this will allow rapid non-invasive diagnosis of the type and/or severity of many common liver diseases (NAFLD/NASH, hepatitis, iron overload).

研究类型

观察性的

注册 (预期的)

60

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

    • England
      • Oxford、England、英国、OX3 9DU
        • 招聘中
        • John Radcliffe Hospital, Oxford University Hospitals NHS Trust
        • 接触:
        • 首席研究员:
          • Jane D Collier, MB ChB MD

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

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study aims to recruit 60 patients due to undergo liver biopsy to establish a diagnosis of liver disease. These patients will be recruited from the Oxford Radcliffe Hospitals clinics by Dr Jane Collier, consultant hepatologist, and her colleagues. Each patient will be scheduled for an ultrasound-guided liver biopsy as part of their usual care. We will ask these patients if they wish to take part in our research study, and offer to arrange the research scans before the biopsy and a time of their choice.

描述

Inclusion Criteria:

  • Male or Female over 18 years of age due for diagnostic liver biopsy
  • Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

  • Any contraindication to magnetic resonance imaging (inc pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).

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

队列和干预

团体/队列
Liver Biopsy patients
All patients due to have a liver biopsy for the assessment of parenchymal liver disease.

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
Liver fat content
大体时间:Day 1
Liver fat content in this study is measured with MR spectroscopy during cardiac-gated breatholds
Day 1
Liver fibrosis
大体时间:Day 1
Liver fibrosis is measured by the T1 relaxation time in milliseconds (continuous variable) using MR. Higher degrees of fibrosis are predicted to have a higher T1 value. These results will be compared to gold-standard histology.
Day 1

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

  • 研究主任:Eleanor Barnes, BSc MBBS PhD、University of Oxford
  • 研究主任:Stefan Neubauer, MD、University of Oxford

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2011年3月1日

初级完成 (预期的)

2012年9月1日

研究完成 (预期的)

2012年9月1日

研究注册日期

首次提交

2012年2月13日

首先提交符合 QC 标准的

2012年3月2日

首次发布 (估计)

2012年3月5日

研究记录更新

最后更新发布 (估计)

2012年3月5日

上次提交的符合 QC 标准的更新

2012年3月2日

最后验证

2012年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • RIAL MR

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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