NCT01543646

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 5, 2012

Status Verified

March 1, 2012

Enrollment Period

1.5 years

First QC Date

February 13, 2012

Last Update Submit

March 2, 2012

Conditions

Liver CirrhosisFatty Liver

Keywords

HepatologyLiver CirrhosisFatty Liver

Outcome Measures

Primary Outcomes (2)

  • Liver fat content

    Liver fat content in this study is measured with MR spectroscopy during cardiac-gated breatholds

    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.

    Day 1

Study Arms (1)

Liver Biopsy patients

All patients due to have a liver biopsy for the assessment of parenchymal liver disease.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Any contraindication to magnetic resonance imaging (inc pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Radcliffe Hospital, Oxford University Hospitals NHS Trust

Oxford, England, OX3 9DU, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33584535DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Liver CirrhosisFatty Liver

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eleanor Barnes, BSc MBBS PhD

    University of Oxford

    STUDY DIRECTOR

  • Stefan Neubauer, MD

    University of Oxford

    STUDY DIRECTOR

Central Study Contacts

Rajarshi Banerjee, BMBCh MA

CONTACT

+44 1865 221875rajarshi.banerjee@cardiov.ox.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2012

First Posted

March 5, 2012

Study Start

March 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 5, 2012

Record last verified: 2012-03

Locations

GB(1)