Functional MRI to Determine Severity of Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03623360
• Other study ID #: IRAS 224109
• Status: Not yet recruiting
• Start date: September 2018
• Est. completion date: February 2019

Study information

• Verified date: August 2018
• Source: University of Leeds
• Contact: Ian Rowe, Dr
• Phone: 0044 0113 206 5667
• Email: i.a.c.rowe[@]leeds.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis

Intervention

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

Locations

Country	Name	City	State
United Kingdom	St. James's University Hospital	Leeds

Sponsors (2)

Lead Sponsor	Collaborator
University of Leeds	The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image quality	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.	Up to 7 days
Primary	The dynamic range of the Total Blood Flow biomarker.	Calculation of the dynamic range of the Total Blood Flow biomarker (ml/100ml/min).	Up to 7 days
Primary	The dynamic range of the Arterial Blood Flow Fraction biomarker.	Calculation of the dynamic range of the Arterial Blood Flow Fraction biomarker (%)	Up to 7 days
Primary	The dynamic range of the Extracellular Volume biomarker.	Calculation of the dynamic range of the Extracellular Volume biomarker (ml/100ml)	Up to 7 days
Primary	The dynamic range of the Intracellular Uptake Rate biomarker.	Calculation of the dynamic range of the Intracellular Uptake Rate biomarker (/100/min)	Up to 7 days
Primary	The dynamic range of the Biliary Excretion Rate biomarker.	Calculation of the dynamic range of the Biliary Excretion Rate biomarker (/100/min)	Up to 7 days
Secondary	Correlation of DCE-MRI measures with clinical outcomes	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)).	Up to 7 days