Clinical trial NCT03623360: Functional MRI to Determine Severity of Cirrhosis
Official title: Prediction of Outcomes in Cirrhosis Using Novel Magnetic Resonance Imaging Biomarkers of Liver Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Liver Fibrosis
Keywords: Gadoxetate disodium
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: The Leeds Teaching Hospitals NHS Trust
First posted: 2018-08-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cirrhosis who attend the Leeds Liver Unit at St James's University Hospital

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.

Eligibility 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.

Primary outcomes:
measure: Image quality
timeFrame: Up to 7 days
measure: The dynamic range of the Total Blood Flow biomarker.
timeFrame: Up to 7 days
measure: The dynamic range of the Arterial Blood Flow Fraction biomarker.
timeFrame: Up to 7 days
measure: The dynamic range of the Extracellular Volume biomarker.
timeFrame: Up to 7 days
measure: The dynamic range of the Intracellular Uptake Rate biomarker.
timeFrame: Up to 7 days
measure: The dynamic range of the Biliary Excretion Rate biomarker.
timeFrame: Up to 7 days
Secondary outcomes:
measure: Correlation of DCE-MRI measures with clinical outcomes
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: St. James's University Hospital
Study officials:
affiliation: University of Leeds
name: Ian Rowe, Dr
role: PRINCIPAL_INVESTIGATOR
References: