NCT03289897

Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan

Non-invasive Rapid Assessment of Non-alcoholic Fatty Liver Disease (NAFLD) Using Magnetic Resonance Imaging With LiverMultiScan (RADIcAL1)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 801 (actual)
• Sponsor: Perspectum · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A multi-centre randomised controlled trial to determine the implementation and health care cost of LiverMultiScan vs. routine methodical assessment (standard care) of Non-alcoholic fatty liver disease (NAFLD) across several European countries.

Detailed description

Non-alcoholic fatty liver disease (NAFLD) is a condition associated with obesity, insulin resistance and heart disease. Research has shown that fatty liver (steatosis) can lead to a spectrum of diseases including low grade inflammation (steatohepatitis or non-alcoholic steatohepatitis (NASH)), cirrhosis or liver failure. The current method used to diagnose liver dysfunction and failure is with percutaneous liver biopsy. This is painful and is not without risk, as the liver is a highly vascular organ. Even with ultrasound guidance, it carries a 1:1000 risk of serious adverse events (e.g. bleeding, infection, bowel perforation). As a result of these factors, liver biopsy is not used in all patients with suspected NAFLD/ NASH unless moderate to severe liver disease is presented or other liver disease need to be excluded. Various diagnostic pathways have arisen, but in the absence of a clearly non-invasive discriminatory test that can stratify normal liver, simple steatosis, steatohepatitis and cirrhosis, there is no standardised pathway. LiverMultiScan has been tested against liver biopsy and has been shown to be the first imaging test that can identify early liver disease and predict clinical outcomes accurately. LiverMultiScan has recently been CE-Marked and FDA-cleared, so is available for clinical use, but as a new test, it is not yet widely established in clinical practice. This study will utilise LiverMultiScan and see if it can be the basis of a viable diagnostic pathway in EU healthcare systems by adopting it in different EU countries, and determining the economic costs and benefits.

Conditions

• NASH - Nonalcoholic Steatohepatitis
• NAFLD
• Metabolic Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	LiverMultiScan	LiverMultiScan is an imaging technique which is able to identify early liver disease.

Timeline

• Start date: 2017-09-05
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2017-09-21
• Last updated: 2023-08-22

Locations

11 sites across 4 countries: Germany, Netherlands, Portugal, United Kingdom