NCT03623360

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

August 1, 2018

Last Update Submit

August 7, 2018

Conditions

Liver CirrhosisLiver Fibrosis

Keywords

Gadoxetate disodium

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • The dynamic range of the Extracellular Volume biomarker.

    Calculation of the dynamic range of the Extracellular Volume biomarker (ml/100ml)

    Up to 7 days

  • 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

  • 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 Outcomes (1)

  • Correlation of DCE-MRI measures with clinical outcomes

    Up to 7 days

Study Arms (1)

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

Interventions

Free breathing DCE-MRIDIAGNOSTIC_TEST

Free breathing DCE-MRI

Patients with liver cirrhosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cirrhosis who attend the Leeds Liver Unit at St James's University Hospital

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. James's University Hospital

Leeds, LS9 7LN, United Kingdom

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ian Rowe, Dr

    University of Leeds

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian Rowe, Dr

CONTACT

0044 0113 206 5667i.a.c.rowe@leeds.ac.uk

Steven Sourbron, Dr

CONTACT

0044 0113 343 6063s.sourbron@leeds.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University of Leeds Academic Fellow and Honorary Consultant Hepatologist

Study Record Dates

First Submitted

August 1, 2018

First Posted

August 9, 2018

Study Start

September 1, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

August 9, 2018

Record last verified: 2018-08

Locations

GB(1)