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Functional MRI to Determine Severity of Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03623360
Recruitment Status : Unknown
Verified August 2018 by Ian Rowe, University of Leeds.
Recruitment status was:  Not yet recruiting
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
The Leeds Teaching Hospitals NHS Trust
Information provided by (Responsible Party):
Ian Rowe, University of Leeds

Study Description
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Brief Summary:

This is a pilot study to investigate the feasibility of a novel MRI technique to assess the severity of liver cirrhosis and predict complications based on functionality and perfusion measurements whilst maintaining image quality.

The principal objective of this pilot study is to assess liver function and the future risk of complications in patients with cirrhosis, using novel techniques and measures based on free-breathing Dynamic Contrast Enhanced MRI.

Specifically the investigators will assess:

  1. Whether sufficient data can be generated in patients with cirrhosis whilst maintaining image quality, and
  2. The dynamic range of DCE-MRI measures in patients with cirrhosis.

This pilot study will, if successful, provide sufficient data to support applications for larger studies to evaluate the clinical utility of a DCE-MRI imaging biomarker in patients with cirrhosis.


Condition or disease Intervention/treatment
Liver Cirrhosis Liver Fibrosis Diagnostic Test: Free breathing DCE-MRI

Detailed Description:

This is a pilot study to investigate the feasibility of a novel MRI technique to assess the severity of liver cirrhosis and predict complications based on functionality and perfusion measurements whilst maintaining image quality.

Recruitment:

Twenty (20) patients with cirrhosis who attend the Leeds Liver Unit at St James's University Hospital will be purposively selected by members of the research team who are also part of the usual care team for these patients in advance of scheduled clinic visits. The selection will be in a way to encompass the full clinical spectrum of liver function within cirrhosis.

Scan:

An intravenous cannula will be inserted to the patient's arm by the radiographer, for the automated administration of contrast agent during the scan. The participant will be asked to remain still on his/her back throughout the duration of the scan.

Patients will undergo a full MRI protocol including morphological imaging, fibrosis scoring tests based on relaxometry and diffusion maps, and the novel functional technique.

After the scan:

The participant will not have to attend any extra clinics or scan appointments. The research team (that includes members of the participants ongoing care team) will continue to track the health condition of the participant over a long-term period (5 years) to collect information with regards to clinical events such as hospital admissions, change in treatment, further procedures and death. The clinical follow-up information will be collected as part of routine care through scheduled ongoing outpatient appointments.

The data acquired during the scans will be analysed using a novel method to quantify liver function and the liver images will be reviewed by an expert radiologist to ensure that the quality of these is sufficient for future clinical application. A cross-sectional data analysis will be performed to identify associations between the functional biomarkers and clinical indices for the assessment of liver fibrosis.

Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prediction of Outcomes in Cirrhosis Using Novel Magnetic Resonance Imaging Biomarkers of Liver Function
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with liver cirrhosis

The cohort includes patients who encompass the full clinical spectrum of liver function within cirrhosis.

The participants will undergo a full MRI protocol for liver screening including morphological imaging, fibrosis scoring tests based on relaxometry and diffusion maps, and our novel functional technique based on free breathing DCE-MRI.

 Diagnostic Test: Free breathing DCE-MRI
Free breathing DCE-MRI


Outcome Measures
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Primary Outcome Measures :
  1. Image quality [ Time Frame: Up to 7 days ]
    The image quality evaluated visually by an expert radiologist using a scoring system. The score levels for the image quality assessments is: 1: non-diagnostic, 2: poor, 3: adequate, 4: good, and 5: excellent.

  2. The dynamic range of the Total Blood Flow biomarker. [ Time Frame: Up to 7 days ]
    Calculation of the dynamic range of the Total Blood Flow biomarker (ml/100ml/min).

  3. The dynamic range of the Arterial Blood Flow Fraction biomarker. [ Time Frame: Up to 7 days ]
    Calculation of the dynamic range of the Arterial Blood Flow Fraction biomarker (%)

  4. The dynamic range of the Extracellular Volume biomarker. [ Time Frame: Up to 7 days ]
    Calculation of the dynamic range of the Extracellular Volume biomarker (ml/100ml)

  5. The dynamic range of the Intracellular Uptake Rate biomarker. [ Time Frame: Up to 7 days ]
    Calculation of the dynamic range of the Intracellular Uptake Rate biomarker (/100/min)

  6. The dynamic range of the Biliary Excretion Rate biomarker. [ Time Frame: Up to 7 days ]
    Calculation of the dynamic range of the Biliary Excretion Rate biomarker (/100/min)


Secondary Outcome Measures :
  1. Correlation of DCE-MRI measures with clinical outcomes [ Time Frame: Up to 7 days ]
    The secondary outcome measure is the correlation between our biomarkers and the clinical scores for the prediction of mortality (Child-Pugh score and the Model to End Stage Liver Disease (MELD)).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cirrhosis who attend the Leeds Liver Unit at St James's University Hospital
Criteria

Inclusion Criteria:

  • Patients who have been diagnosed with liver cirrhosis using standard methods (liver biochemistry, ultrasound based elastography and liver biopsy).

Exclusion Criteria:

  • Pregnancy
  • Allergy/intolerance to Gadolinium based contrast agents
  • Severe renal impairment
  • Severe respiratory disease
  • Inability to undergone MRI due to the presence of metal or electronic implants affected by the magnetic field.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623360


Contacts
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Contact: Ian Rowe, Dr 0044 0113 206 5667 i.a.c.rowe@leeds.ac.uk
Contact: Steven Sourbron, Dr 0044 0113 343 6063 s.sourbron@leeds.ac.uk

Locations
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United Kingdom
St. James's University Hospital
Leeds, United Kingdom, LS9 7LN
Contact: Ian Rowe, Dr    0044 0113 206 5667    i.a.c.rowe@leeds.ac.uk   
Sponsors and Collaborators
University of Leeds
The Leeds Teaching Hospitals NHS Trust
Investigators
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Principal Investigator: Ian Rowe, Dr University of Leeds
More Information
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Responsible Party: Ian Rowe, University of Leeds Academic Fellow and Honorary Consultant Hepatologist, University of Leeds
ClinicalTrials.gov Identifier: NCT03623360    
Other Study ID Numbers: IRAS 224109
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

The information about the health and care of the participants may be provided to researchers running other research studies in this organisation and in other organisations. The information will only be used by organisations and researchers to conduct research in accordance with the United Kingdom Policy Framework for Health and Social Care Research. This information will not identify the individuals and will not be combined with other information in a way that could identify the participants.

The images obtained from the MRI scan may also be shared anonymously with Siemens, Inc - the company who have developed the techniques to allow scans to be done without breath holding. These images may be used to improve the way that the scans are processed as well as in illustrations of the quality of the images that can be obtained using this technique.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ian Rowe, University of Leeds:
Gadoxetate disodium
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases