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

April 3, 2012
September 17, 2012
May 2009
September 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01572064 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Magnetic Resonance Imaging in the Evaluation of Liver Fibrosis
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Liver Fibrosis
  • Procedure: Blood sample
    1 fasted blood sample taken for metabolomics
  • Other: MRI Scan
    1 single visit for MRI and MRS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
134
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01572064
09/H0403/1
No
University of Nottingham
University of Nottingham
Not Provided
Principal Investigator: Guruprasad P Aithal, PhD University of Nottingham
University of Nottingham
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP