Extract

Background and study aims Chronic liver disease is a major contributor to ill health in western society and is the fifth biggest killer in England and Wales. In the UK it is the only major cause of death that is becoming more common. The health problems associated with chronic liver disease are mainly due to scarring in the liver, which is known as fibrosis. The current best method for assessing fibrosis is a liver biopsy. This is where a needle is used to take a sample of liver tissue to be analysed in the lab. A liver biopsy can be used to tell your doctor about the possible cause for liver damage and how bad that damage is. Having a liver biopsy is uncomfortable and carries a small but significant risk. This risk means that it is not often justified to repeat biopsies to monitor progress in liver damage over time or to monitor a patient’s response to treatment. There are several techniques to assess liver damage without a biopsy but at the moment these are not as reliable as a liver biopsy. The main problem with these ‘non-invasive’ methods of assessing fibrosis are that they have a limited ability to detect the early stages of fibrosis, where patients have the most to gain. This study aims to assess a new magnetic resonance imaging (MRI) technique called LiverMultiscan for the staging and long-term monitoring of chronic liver disease. There are three strands to this study. The first is called Comprehensive Assessment of the Liver with MRI (CALM). This compares LiverMultiscan with liver biopsy. The second and third are called Longitudinal Assessment with MRI in PSC (LAMP) and Longitudinal Assessment with MRI in Autoimmune Liver Disease (LAMALD). These look at the ability of LiverMultiscan to track the progression of autoimmune liver disease. Who can participate? CALM: men or women aged 18 or over having a liver biopsy as part of their routine care to investigate a known or suspected liver condition. LAMP/LAMALD: men or women aged 18 or over with autoimmune liver disease who do not need a biopsy. What does the study involve? CALM: we will offer a LiverMultiscan to patients who are having a liver biopsy as part of their routine care. We will compare the data from the LiverMultiscan with the results from the biopsy. Participants will also have a blood test and a quick, painless ultrasound scan called a Fibroscan. LAMP/LAMALD: we will offer a LiverMultiscan to patients who have autoimmune liver disease. This includes conditions such as primary sclerosing cholangitis (PSC), primary biliary cirrhosis (PBC) and autoimmune hepatitis. People taking part in this part of the study do not need a liver biopsy. We will ask these people to attend for a LiverMultiscan at the start of the study and again 18 months later to see if LiverMultiscan can track any changes in the liver over time. In each part of the study patients will continue with their routine care throughout. No one will miss out on any treatment by taking part. What are the possible benefits and risks of participating? There is no immediate benefit to taking part; however, this study may develop a technique that could benefit you or others in the future by making the assessment and monitoring of liver disease quicker and safer. MRI scans are safe and painless and so there are no risks to taking part in this project. Where is the study run from? CALM is being carried out between the Universities of Birmingham and Edinburgh. The lead centre is Birmingham and the project will be co-ordinated from there. LAMP/LAMALD take place in Birmingham only. When is the study starting and how long is it expected to run for? We started recruiting people to the study in January 2014. The study will continue until September 2018. Who is funding the study? The CALM & LAMP studies are funded by the UK’'s innovation agency, the Technology Strategy Board. LAMALD is funded by the NIHR Rare Diseases Translation Research Collaboration. Who is the main contact? Dr Katherine Arndtz (Clinical Research Fellow) [email protected]

Inclusion criteria

• Known or suspected liver disease

Links

• isrctn
• ictrp