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Functional MRI to Determine Severity of Cirrhosis

Prediction of Outcomes in Cirrhosis Using Novel Magnetic Resonance Imaging Biomarkers of Liver Function

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03623360
Enrollment
20
Registered
2018-08-09
Start date
2018-09-30
Completion date
2019-02-28
Last updated
2018-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Liver Fibrosis

Keywords

Gadoxetate disodium

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.

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.

Interventions

DIAGNOSTIC_TESTFree breathing DCE-MRI

Free breathing DCE-MRI

Sponsors

The Leeds Teaching Hospitals NHS Trust
CollaboratorOTHER
University of Leeds
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
The dynamic range of the Arterial Blood Flow Fraction biomarker.Up to 7 daysCalculation of the dynamic range of the Arterial Blood Flow Fraction biomarker (%)
Image qualityUp to 7 daysThe 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.Up to 7 daysCalculation of the dynamic range of the Total Blood Flow biomarker (ml/100ml/min).
The dynamic range of the Biliary Excretion Rate biomarker.Up to 7 daysCalculation of the dynamic range of the Biliary Excretion Rate biomarker (/100/min)
The dynamic range of the Extracellular Volume biomarker.Up to 7 daysCalculation of the dynamic range of the Extracellular Volume biomarker (ml/100ml)
The dynamic range of the Intracellular Uptake Rate biomarker.Up to 7 daysCalculation of the dynamic range of the Intracellular Uptake Rate biomarker (/100/min)

Secondary

MeasureTime frameDescription
Correlation of DCE-MRI measures with clinical outcomesUp to 7 daysThe 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)).

Countries

United Kingdom

Contacts

Primary ContactIan Rowe, Dr
i.a.c.rowe@leeds.ac.uk0044 0113 206 5667
Backup ContactSteven Sourbron, Dr
s.sourbron@leeds.ac.uk0044 0113 343 6063

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026