Liver CirrhosisRIALNCT01543646
Multiparametric MR for Rapid Imaging Assessment of the Liver
An observational study of Liver Cirrhosis and Fatty Liver, run by University of Oxford at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Fatty Liver
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Any contraindication to magnetic resonance imaging (inc pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
John Radcliffe Hospital, Oxford University Hospitals NHS Trust
Oxford, England, OX3 9DU
Rajarshi Banerjee, BM BCh MA, +44 1865 221875, rajarshi.banerjee@cardiov.ox.ac.uk
Jane D Collier, MB ChB MD
About this study
Official title: Rapid Imaging Assessment of the Liver Using Multiparametric Magnetic Resonance
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.
Read more
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.
Read the 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).
- Conditions
- Liver Cirrhosis, Fatty Liver
- Keywords
- Hepatology, Liver Cirrhosis, Fatty Liver
- Medical subject headings
- Liver Cirrhosis, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Liver Biopsy patients | All patients due to have a liver biopsy for the assessment of parenchymal liver disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fat content
Liver fat content in this study is measured with MR spectroscopy during cardiac-gated breatholds
Measured: Day 1
Liver fibrosis
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startMar 2011
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation, Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Eleanor Barnes, BSc MBBS PhD, Study director, University of OxfordStefan Neubauer, MD, Study director, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543646
- Sponsor's protocol ID
- RIAL MR
- Acronym
- RIAL
- Status last verified
- Mar 2012
- First submitted
- 13 Feb 2012
- Last updated
- 5 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Dennis A, Kelly MD, Fernandes C, Mouchti S, Fallowfield JA, Hirschfield G, Pavlides M, Harrison S, Chakravarthy MV, Banerjee R, Sanyal A. Correlations Between MRI Biomarkers PDFF and cT1 With Histopathological Features of Non-Alcoholic Steatohepatitis. Front Endocrinol (Lausanne). 2021 Jan 27;11:575843. doi: 10.3389/fendo.2020.575843. eCollection 2020.
PubMed 33584535
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Imaging Assessment of the Liver Using Multiparametric Magnetic Resonance
- ClinicalTrials.gov ID
- NCT01543646
- Acronym / sponsor ID
- RIAL / RIAL MR
- Conditions
- Liver Cirrhosis, Fatty Liver
- Keywords
- Hepatology, Liver Cirrhosis, Fatty Liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- British Heart Foundation, Oxford University Hospitals NHS Trust
- Study start
- Mar 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Biopsy patients | – | –All patients due to have a liver biopsy for the assessment of parenchymal liver disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Any contraindication to magnetic resonance imaging (inc pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Liver fat content
Time frame: Day 1
Liver fat content in this study is measured with MR spectroscopy during cardiac-gated breatholds
Liver fibrosis
Time frame: Day 1
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2012.
- Derived from this study: PubMed 33584535Dennis A, Kelly MD, Fernandes C, Mouchti S, Fallowfield JA, Hirschfield G, Pavlides M, Harrison S, Chakravarthy MV, Banerjee R, Sanyal A. Correlations Between MRI Biomarkers PDFF and cT1 With Histopathological Features of Non-Alcoholic Steatohepatitis. Front Endocrinol (Lausanne). 2021 Jan 27;11:575843. doi: 10.3389/fendo.2020.575843. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleanor Barnes, BSc MBBS PhD study director
University of Oxford
Stefan Neubauer, MD study director
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Fatty Liver, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rajarshi Banerjee, BMBCh MA (+44 1865 221875, rajarshi.banerjee@cardiov.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver fat content (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01543646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2012.