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LiverMultiscan - replacing liver biopsy

LiverMultiscan - replacing liver biopsy: an observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN39463479
Enrollment
360
Registered
2014-01-27
Start date
2014-01-01
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Known or suspected liver disease Digestive System Diseases of liver

Interventions

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 mi

Sponsors

University of Birmingham (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

Exclusion criteria: 1. Unable or unwilling to give informed consent 2. Liver biopsy targeted at a distinct liver lesion 3. Any contraindication to MRI

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026