NCT03289897

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
801

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
4 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

September 5, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 21, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

3.3 years

First QC Date

September 5, 2017

Last Update Submit

August 21, 2023

Conditions

NASH - Nonalcoholic SteatohepatitisNAFLDMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Patient satisfaction: questionnaire

    1 year

  • Certainty of diagnosis

    1 year

  • Frequency of diagnosis

    1 year

  • Time to diagnosis

    1 year

  • Measure resource use

    1 year

  • +2 more secondary outcomes

Study Arms (2)

Study Arm-LiverMultiScan

EXPERIMENTAL

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

Diagnostic Test: LiverMultiScan

Control Arm

NO INTERVENTION

Standard of care as per guidelines of the local centre

Interventions

LiverMultiScanDIAGNOSTIC_TEST

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

Study Arm-LiverMultiScan

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • imaging suggestive of Fatty liver disease.
  • Presence of ≥ 3 of the following criteria:
  • insulin resistance or type 2 diabetes mellitus
  • obesity (BMI \> 30 or waist-to-hip ratio \> 1.00 for men / \> 0.85 for women)
  • hypertension (≥ 130/85 mmHg)
  • elevated triglycerides (≥ 1.7 mmol/l)
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University Hospital Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Leiden University Medical Center

Leiden, South Holland, 2333, Netherlands

Location

University of Coimbra

Coimbra, Centro, 3004-531, Portugal

Location

Southampton University Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Aintree Hospital

Liverpool, Merseyside, L9 7AL, United Kingdom

Location

Ninewells Hospital

Dundee, DD2 1SG, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Glasgow Royal Infirmary

Glasgow, G40SF, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

St George's Hospital

London, SW170Q2, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 24036007BACKGROUND

  • 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.

    PMID: 26471505BACKGROUND

  • 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.

    PMID: 33104014DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseMetabolic Syndrome

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Matthias Dollinger, MD

    University Hospital Ulm

    PRINCIPAL INVESTIGATOR

  • Dimitar Tonev, MD

    Perspectum Diagnostics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 21, 2017

Study Start

September 5, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)DE(1)GB(8)PT(1)