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Magnetic Resonance Imaging in the Evaluation of Liver Fibrosis (Mrker)

2012年9月17日 更新者:University of Nottingham

Magnetic Resonance Imaging in the Evaluation of Hepatic Fibrosis: Search for MRI Biomarker

The main purpose of this pilot study is to evaluate non-invasive magnetic resonance imaging (MRI) techniques in the detection and grading of liver fibrosis, so that the investigators can reduce the need of invasive techniques such as liver biopsy and transjugular hepatic venous portal pressure gradient (HVPG) measurements to assess the degree of liver scarring and portal hypertension.

研究概览

地位

完全的

条件

详细说明

In chronic liver diseases of all aetiology, persistent hepatocyte injury leads to progressive fibrosis and cirrhosis. In the UK, 76 adults per 100,000 population have cirrhosis and its incidence is increasing (Fleming et al., J Hepatol 2008,49,p732-738). Currently, liver biopsy is the only method of assessing the degree of fibrosis. However, liver biopsy is associated with limitations such as sampling error, intra- and inter-observer variations in interpretation and adverse events (Morbidity 1-5% and mortality between 1 in 1,000 to 1 in 10,000), hence considered a 'Silver (rather than Gold) standard'. Assessment of degree of fibrosis is necessary to stage the disease process, determine the timing of intervention and for prognosis.

Development of portal hypertension as a result of progressive fibrosis is a landmark in the natural history of chronic liver diseases as it accounts for majority of complications and clinical outcome. The degree of fibrosis and presence of portal hypertension will determine whether patients are included in surveillance programmes for the early detection of varices and hepatocellular carcinoma. As with assessment of the degree of fibrosis, the presence and degree of portal hypertension can only be determined by transjugular hepatic venous portal pressure gradient (HVPG) measurements, another investigation that is also hampered by access, costs, risks and difficulty of serial measurements.

A variety of evolving techniques using magnetic resonance imaging (MRI) (Talwalkar et al., Hepatology 2008; 47:332-42) if validated and established, have potential to replace liver biopsy and HVPG measurements. The non-invasive nature of MRI, its ability to estimate amount of accumulated fat (1H MR spectroscopy), cell membrane turnover (31P-MRS), iron (relaxometry), fibrosis (MR elastography) as well as an ability to assess portal blood flow and hepatic perfusion (Arterial Spin Labelling (ASL)) make it an ideal tool to evaluate liver structure and function and to stage the liver disease. Most recently, MRI has seen unprecedented developments in terms of accuracy of quantitation and speed of assessment, which has been realised due to data-sharing ultra-fast MRI sequences, multispectral analysis, and refinement of elastography methods. Validation of evolving MRI techniques against liver biopsies, HVPG and metabolomics is a critical step prior to its translation into clinical applications by the creation of MRI biomarkers.

研究类型

介入性

注册 (实际的)

134

阶段

  • 不适用

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

    • Nottinghamshire
      • Nottingham、Nottinghamshire、英国、NG7 2UH
        • NDDC BRU and Sir Peter Mansfield Magnetic Resonance Centre

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 至 80年 (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:

  • Liver biopsy within the last 3 months
  • Underlying chronic liver disease- hepatitis C, alcoholic liver disease, non-alcoholic fatty liver disease, hepatitis B, haemochromatosis or where biopsy is considered normal.
  • Ability to consent to participate in the study

Exclusion Criteria:

  • Inadequate biopsy length for histology
  • Absolute contraindications for MRI
  • Abdominal/waist circumference greater than 112 cm (44 inches), due to scanner bore constraints
  • Pregnant women

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:不适用
  • 介入模型:单组作业
  • 屏蔽:单身的

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
Diagnostic accuracy of MRI in the detection of fibrosis and advanced fibrosis compared with histology.
大体时间:MRI within 3 months of liver biopsy
MRI and MRS
MRI within 3 months of liver biopsy

次要结果测量

结果测量
措施说明
大体时间
Diagnostic accuracy of MRI in the detection of fibrosis and advanced fibrosis compared with serological markers.
大体时间:Blood Test taken on same day as MRI
Metabolomics analysis
Blood Test taken on same day as MRI

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:Guruprasad P Aithal, PhD、University of Nottingham

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

2009年5月1日

初级完成 (实际的)

2012年9月1日

研究完成 (实际的)

2012年9月1日

研究注册日期

首次提交

2012年4月3日

首先提交符合 QC 标准的

2012年4月4日

首次发布 (估计)

2012年4月5日

研究记录更新

最后更新发布 (估计)

2012年9月18日

上次提交的符合 QC 标准的更新

2012年9月17日

最后验证

2012年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 09/H0403/1

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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