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

Metabolic Syndrome Clinical Trial

— RADIcAL1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289897
• Other study ID #: PJM124
• Status: Completed
• Phase: N/A
• Start date: September 5, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2023
• Source: Perspectum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male and female patients aged 18-75 years, due to undergo evaluation for suspected non-alcoholic fatty liver disease
• Presence of:
• elevated liver function tests (ALT, AST or GGT = 1.5 x upper limit of normal and = 5 x upper limit of normal) OR
• imaging suggestive of Fatty liver disease. OR

Presence of = 3 of the following criteria:

1. insulin resistance or type 2 diabetes mellitus

2. obesity (BMI > 30 or waist-to-hip ratio > 1.00 for men / > 0.85 for women)

3. hypertension (= 130/85 mmHg)

4. elevated triglycerides (= 1.7 mmol/l)

5. low HDL-cholesterol (< 1.05 mmol/l for men / < 1.25 mmol/l for women)

• Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

• The participant may not enter the study if they have any contraindication to magnetic resonance imaging (inc pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
• Patients with proven liver disease other than NAFLD.
• Liver transplantation
• Patients that present with clinical signs of chronic liver failure (variceal bleeding, ascites, overt encephalopathy)
• Pregnancy
• Alcohol over-use/ abuse as determined by local guidelines
• Patient with known malignant liver tumours and those with any malignancy with life expectancy < 36 months
• Heart failure NYHA stages II-IV
• Severe mental illness
• Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study

Related Conditions & MeSH terms

• Fatty Liver
• Metabolic Syndrome
• NAFLD
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

Diagnostic Test:
• LiverMultiScan
LiverMultiScan is an imaging technique which is able to identify early liver disease.

Locations

Country	Name	City	State
Germany	University Hospital Ulm	Ulm	Baden-Württemberg
Netherlands	Leiden University Medical Center	Leiden	South Holland
Portugal	University of Coimbra	Coimbra	Centro
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	Aintree Hospital	Liverpool	Merseyside
United Kingdom	King's College Hospital	London
United Kingdom	St George's Hospital	London
United Kingdom	Southampton University Hospital	Southampton	Hampshire

Sponsors (12)

Lead Sponsor	Collaborator
Perspectum	Glasgow Royal Infirmary, King's College Hospital NHS Trust, Leiden University Medical Center, Liverpool University Hospitals NHS Foundation Trust, NHS Greater Glasgow and Clyde, Ninewells Hospital, Royal Infirmary of Edinburgh, St George's University Hospitals NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, University Hospital Ulm, University of Coimbra

Countries where clinical trial is conducted

Germany,  Netherlands,  Portugal,  United Kingdom, 

References & Publications (2)

Banerjee R, Pavlides M, Tunnicliffe EM, Piechnik SK, Sarania N, Philips R, Collier JD, Booth JC, Schneider JE, Wang LM, Delaney DW, Fleming KA, Robson MD, Barnes E, Neubauer S. Multiparametric magnetic resonance for the non-invasive diagnosis of liver disease. J Hepatol. 2014 Jan;60(1):69-77. doi: 10.1016/j.jhep.2013.09.002. Epub 2013 Sep 12. — View Citation

Pavlides M, Banerjee R, Sellwood J, Kelly CJ, Robson MD, Booth JC, Collier J, Neubauer S, Barnes E. Multiparametric magnetic resonance imaging predicts clinical outcomes in patients with chronic liver disease. J Hepatol. 2016 Feb;64(2):308-315. doi: 10.1016/j.jhep.2015.10.009. Epub 2015 Nov 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate whether the introduction of LiverMultiScan as a standardised diagnostic test for liver disease can prove a cost-effective method in different EU territories.	Proportion of patients with suspected NAFLD incurring liver related hospital consultations and/or liver biopsies, from the date of randomisation to the end of the study follow-up.	1 year
Secondary	Patient satisfaction: questionnaire	Patient feedback from patient satisfaction questionnaire, at baseline, and all follow-up visits to the end of the study.	1 year
Secondary	Certainty of diagnosis	Certainty of diagnosis is defined as binary (yes/no vs. unlikely/probable) at baseline and all follow-up visits to the end of the study.	1 year
Secondary	Frequency of diagnosis	Frequency of diagnosis is defined as binary (yes/probable vs. no/unlikely) at baseline and all follow-up visits to the end of the study.	1 year
Secondary	Time to diagnosis	Time from randomisation to diagnosis by the physician, as recorded at final follow-up visit.	1 year
Secondary	Measure resource use	Rates of liver related outpatient investigations/consultations/hospital admissions per 400 patients during the study.	1 year
Secondary	Cost effectiveness of LiverMultiScan	Cost of LiverMultiScan based on randomised comparison.	1 year
Secondary	Personnel skills required for diagnosis	Percentage of total consultations performed by a specialist, at each specialist medical category, from date of randomisation to end of study.	1 year