LiverMultiscan - replacing liver biopsy

• Register: ISRCTN
• Last refreshed on: 15 April 2024
• Main ID: ISRCTN39463479
• Date of registration: 27/01/2014
• Prospective Registration: No
• Primary sponsor: University of Birmingham (UK)
• Public title: LiverMultiscan - replacing liver biopsy
• Scientific title: LiverMultiscan - replacing liver biopsy: an observational study
• Date of first enrolment: 01/01/2014
• Target sample size: 360
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN39463479
• Study type: Observational
• Study design: Two centre cross-sectional observational study (Diagnostic)
• Phase: Not Applicable

Countries of recruitment

England, United Kingdom

Contacts

• Name: Gideon Hirschfield

Key inclusion & exclusion criteria

Inclusion criteria: CALM: Men and women aged 18 or over who are having a liver biopsy as part of their routine care.

LAMP/LAMALD: Men and women aged 18 or over with an autoimmune liver disease.
Exclusion criteria: 1. Unable or unwilling to give informed consent
2. Liver biopsy targeted at a distinct liver lesion
3. Any contraindication to MRI

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Known or suspected liver disease
Digestive System
Diseases of liver

Intervention(s)

MRI scan. For this scan participants will fill in a MRI safety questionnaire to ensure there is no risk from the scan and then lie in a comfortable position in the scanner. The scan takes around 30 minutes to complete. Participants will need to lie still and hold their breath for short periods of time while the pictures are taken. We will measure the amount of fibrosis, fat and iron in the liver.

Fibroscan. This is a painless and quick ultrasound technique for measuring the stiffness of the liver. Participants will live on their back with the right arm behind the head. The probe is put against the skin on the right side of the tummy for about 5 minutes while the readings are taken.

Blood tests. These are routine tests of liver and kidney function as well as some blood markers of liver disease. We will try and take these tests at the same time as participants have clinically necessary blood tests to cut down on the number of needles.

Primary Outcome(s)

Correlation between the MRI result and liver biopsy histology

For CALM the primary outcome measure is the correlation between the MRI result and liver biopsy histology. We will compare the results from participants' MRI scan with the results from their liver biopsy. There is no follow up in the main part of the study. There will be a single MRI scan and a single liver biopsy done as close together as possible.

For LAMP/LAMALD the primary outcome measure is changes on the MRI scan over time. There will be two MRI scans: the first on study entry and the second 18 months later.

Secondary Outcome(s)

Correlation between MRI results and other non-invasive markers of liver disease such as blood markers and Fibroscan.
We will assess how well LiverMultiscan compares to blood markers and Fibroscan in the diagnosis of liver disease. There is no follow up and all investigations will be done as close together as possible.

Secondary ID(s)

RG_13-260

Source(s) of Monetary Support

Technology Strategy Board (UK) Ref: 101679, NIHR Rare Disease Translational Research Collaboration

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; West Midlands - Black Country Research Ethic Committee, 09/01/2014, IRAS reference number: 140543, REC ref: 14/WM/0010

Results

• Results available: Yes
• Date Completed: 01/09/2018