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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01572064
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : September 18, 2012
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Liver Fibrosis Procedure: Blood sample Other: MRI Scan Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Imaging in the Evaluation of Hepatic Fibrosis: Search for MRI Biomarker
Study Start Date : May 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Intervention Details:
  • Procedure: Blood sample
    1 fasted blood sample taken for metabolomics
  • Other: MRI Scan
    1 single visit for MRI and MRS

Primary Outcome Measures :
  1. Diagnostic accuracy of MRI in the detection of fibrosis and advanced fibrosis compared with histology. [ Time Frame: MRI within 3 months of liver biopsy ]
    MRI and MRS

Secondary Outcome Measures :
  1. Diagnostic accuracy of MRI in the detection of fibrosis and advanced fibrosis compared with serological markers. [ Time Frame: Blood Test taken on same day as MRI ]
    Metabolomics analysis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01572064

United Kingdom
NDDC BRU and Sir Peter Mansfield Magnetic Resonance Centre
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Principal Investigator: Guruprasad P Aithal, PhD University of Nottingham

Responsible Party: University of Nottingham Identifier: NCT01572064     History of Changes
Other Study ID Numbers: 09/H0403/1
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: September 18, 2012
Last Verified: September 2012

Keywords provided by University of Nottingham:
liver biopsy
serological markers

Additional relevant MeSH terms:
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases