Prediction of Outcomes in Cirrhosis Using Novel Magnetic Resonance Imaging Biomarkers of Liver Function
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Leeds
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Image quality
Study Overview
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:
- Whether sufficient data can be generated in patients with cirrhosis whilst maintaining image quality, and
- 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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
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).
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 (%)
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)
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)
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 Outcomes
- Correlation of DCE-MRI measures with clinical outcomes(Up to 7 days)
Investigators
Ian Rowe
University of Leeds Academic Fellow and Honorary Consultant Hepatologist
University of Leeds