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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01572064
First received: April 3, 2012
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

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 Intervention
Liver Fibrosis
Procedure: Blood sample
Other: MRI Scan

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Imaging in the Evaluation of Hepatic Fibrosis: Search for MRI Biomarker

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Diagnostic accuracy of MRI in the detection of fibrosis and advanced fibrosis compared with histology. [ Time Frame: MRI within 3 months of liver biopsy ] [ Designated as safety issue: No ]
    MRI and MRS


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Metabolomics analysis


Enrollment: 134
Study Start Date: May 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Blood sample
    1 fasted blood sample taken for metabolomics
    Other: MRI Scan
    1 single visit for MRI and MRS
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572064

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

Publications:
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01572064     History of Changes
Other Study ID Numbers: 09/H0403/1
Study First Received: April 3, 2012
Last Updated: September 17, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Nottingham:
MRI
liver biopsy
serological markers

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

ClinicalTrials.gov processed this record on October 19, 2014