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

NCT ID: NCT03289897

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 801 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-05
• Study Completion Date: 2020-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Study Arm-LiverMultiScan

Patients will be scanned using the LiverMultiScan. Follow-up will be determined by the results of the scan.

Group Type: EXPERIMENTAL

LiverMultiScan

Intervention Type: DIAGNOSTIC_TEST

LiverMultiScan is an imaging technique which is able to identify early liver disease.

Control Arm

Standard of care as per guidelines of the local centre

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LiverMultiScan

LiverMultiScan is an imaging technique which is able to identify early liver disease.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Coimbra

OTHER

Sponsor Role: collaborator

University Hospital Ulm

OTHER

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: collaborator

Liverpool University Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role: collaborator

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role: collaborator

King's College Hospital NHS Trust

OTHER

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: collaborator

Glasgow Royal Infirmary

OTHER

Sponsor Role: collaborator

Ninewells Hospital

OTHER

Sponsor Role: collaborator

Royal Infirmary of Edinburgh

OTHER

Sponsor Role: collaborator

St George's University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Perspectum

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias Dollinger, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ulm

Dimitar Tonev, MD

Role: PRINCIPAL_INVESTIGATOR

Perspectum Diagnostics

Locations

University Hospital Ulm

Ulm, Baden-Wurttemberg, Germany

Leiden University Medical Center

Leiden, South Holland, Netherlands

University of Coimbra

Coimbra, Centro, Portugal

Southampton University Hospital

Southampton, Hampshire, United Kingdom

Aintree Hospital

Liverpool, Merseyside, 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

King's College Hospital

London, , United Kingdom

St George's Hospital

London, , United Kingdom

Countries

Germany; Netherlands; Portugal; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 24036007 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26471505 (View on PubMed)

Tonev D, Shumbayawonda E, Tetlow LA, Herdman L, French M, Rymell S, Thomaides-Brears H, Caseiro-Alves F, Castelo-Branco M, Ferreira C, Coenraad M, Lamb H, Beer M, Kelly M, Banerjee R, Dollinger M; RADIcAL1. The Effect of Multi-Parametric Magnetic Resonance Imaging in Standard of Care for Nonalcoholic Fatty Liver Disease: Protocol for a Randomized Control Trial. JMIR Res Protoc. 2020 Oct 26;9(10):e19189. doi: 10.2196/19189.

Reference Type: DERIVED

PMID: 33104014 (View on PubMed)

Other Identifiers

PJM124

Identifier Type: -

Identifier Source: org_study_id