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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Oxford.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
British Heart Foundation
Oxford University Hospitals NHS Trust
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01543646
First received: February 13, 2012
Last updated: March 2, 2012
Last verified: March 2012
  Purpose

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.


Condition
Liver Cirrhosis
Fatty Liver

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rapid Imaging Assessment of the Liver Using Multiparametric Magnetic Resonance

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Liver fat content [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Liver fat content in this study is measured with MR spectroscopy during cardiac-gated breatholds

  • Liver fibrosis [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Fresh frozen plasma, frozen serum, and whole blood for DNA analysis


Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Liver Biopsy patients
All patients due to have a liver biopsy for the assessment of parenchymal liver disease.

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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).
  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: NCT01543646

Contacts
Contact: Rajarshi Banerjee, BMBCh MA +44 1865 221875 rajarshi.banerjee@cardiov.ox.ac.uk

Locations
United Kingdom
John Radcliffe Hospital, Oxford University Hospitals NHS Trust Recruiting
Oxford, England, United Kingdom, OX3 9DU
Contact: Rajarshi Banerjee, BM BCh MA    +44 1865 221875    rajarshi.banerjee@cardiov.ox.ac.uk   
Principal Investigator: Jane D Collier, MB ChB MD         
Sponsors and Collaborators
University of Oxford
British Heart Foundation
Oxford University Hospitals NHS Trust
Investigators
Study Director: Eleanor Barnes, BSc MBBS PhD University of Oxford
Study Director: Stefan Neubauer, MD University of Oxford
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01543646     History of Changes
Other Study ID Numbers: RIAL MR
Study First Received: February 13, 2012
Last Updated: March 2, 2012
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by University of Oxford:
Hepatology
Liver Cirrhosis
Fatty Liver

Additional relevant MeSH terms:
Fatty Liver
Liver Cirrhosis
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on October 30, 2014