MRI in Portal Hypertension (MRQuee)

January 14, 2014 updated by: University of Nottingham

Quantitative Magnetic Resonance Imaging (MRI) Techniques in the Evaluation and Estimation of Portal Hypertension

Death from chronic liver disease has doubled in the UK over the last decade. This is largely due to the rise in liver disease from excess alcohol consumption, obesity related fatty liver disease and hepatitis B & C infections. The current 'liver tests' only identify liver injury when the damage is at an advanced stage. They neither estimate the degree of injury accurately nor help judge prognosis. The complications from chronic liver disease result mainly from raised pressures within the liver. We currently measure this pressure by passing a long catheter through the jugular vein in the neck into the liver. This invasive test does carry a small yet significant risk of complications and is not available outside specialised liver centres. Raised pressure within the liver is also associated with changes in the microorganisms within the gut. This leads to increased infective complications among patients with liver cirrhosis.

We aim to noninvasively measure the pressures within the liver using Magnetic Resonance Imaging (MRI). We will recruit 49 patients with chronic liver disease who have had liver pressure measurements as part of their routine clinical assessment. The participants will attend the Biomedical Research Unit and the MR Centre for a single 2hour visit. We will also collect blood, urine and stool samples from them.

The diagnostic accuracy of the quantitative MRI techniques will be validated against the pressures obtained via the invasive test. The quantitative MRI techniques will also correlated with biomarkers of liver injury obtained from blood and urine samples. The stool sample obtained will be used to characterise the gut microorganisms in these patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Derby, United Kingdom
      • Nottingham, United Kingdom, NG72UH
        • Recruiting
        • Nottingham University Hospitals NHS Trust
        • Contact:
        • Sub-Investigator:
          • Naaventhan Palaniyappan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants will be recruited from liver services from Nottingham University Hospitals NHS Trust and Derby Hospitals NHS Foundation Trust. All the patients will have had HVPG measurements performed for clinical indications.

Description

Inclusion Criteria:

  1. Patients of more than 18 years of age.
  2. Patients who have had HVPG measurements within the last 6 weeks.
  3. Underlying portal hypertension due to chronic liver disease - alcoholic liver disease, non-alcoholic fatty liver disease (NAFLD), chronic hepatitis B or C and heamochromatosis.
  4. Patients investigated with a clinical suspicion of portal hypertension, but have normal portal pressures on HVPG measurements.
  5. Ability to consent to participate in the study.

Exclusion Criteria:

  1. Patients with underlying diseases which are NOT related to alcohol excess, NAFLD, chronic hepatitis B, C or haemochromatosis.
  2. Abdominal/waist circumference greater than 112 cm (44 inches) due to scanner bore constraints
  3. Pregnant women.
  4. Absolute contraindications for MRI. Any patient that indicates on the MR safety questionnaire that they have or suspect they may have metal in their eye(s) will require an x-ray prior to their MRI scan confirming that their eye(s) are free from metal. This will be verified using previous x-ray records. Any patient whose previous records indicate that they may have had metal in their eye(s) or any patients without any x-ray records will be x-rayed for the purposes of this study. Any patient having current metal in their eye(s), will not be given an MRI scan and therefore will not be recruited into the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with HVPG measurements
Patients having HVPG measurements for clinical reasons will be recruited to undergo research MRI scan.
Procedure: MRI Scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic accuracy of quantitative MR techniques in the detection and grading the degree of portal hypertension compared to HVPG measurements.
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between quantitative MR techniques and serum biomarkers of fibrosis.
Time Frame: 18 months
18 months
Characterisation of the gut microbiota in patients with portal hypertension.
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

  • Principal Investigator: Guruprasad Aithal, NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases, Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

December 20, 2012

First Submitted That Met QC Criteria

December 20, 2012

First Posted (Estimate)

December 28, 2012

Study Record Updates

Last Update Posted (Estimate)

January 15, 2014

Last Update Submitted That Met QC Criteria

January 14, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12092

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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