Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03289897
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03289897
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
University of Coimbra
University Hospital Ulm
Leiden University Medical Center
Liverpool University Hospitals NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
King's College Hospital NHS Trust
NHS Greater Glasgow and Clyde
Glasgow Royal Infirmary
Ninewells Hospital
Royal Infirmary of Edinburgh
St George's University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Perspectum Diagnostics Ltd

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.

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis NAFLD Metabolic Syndrome Diagnostic Test: LiverMultiScan Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1072 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Non-invasive Rapid Assessment of Non-alcoholic Fatty Liver Disease (NAFLD) Using Magnetic Resonance Imaging With LiverMultiScan (RADIcAL1)
Actual Study Start Date : September 4, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: Study Arm-LiverMultiScan
Patients will be scanned using the LiverMultiScan. Follow-up will be determined by the results of the scan.
Diagnostic Test: LiverMultiScan
LiverMultiScan is an imaging technique which is able to identify early liver disease.

No Intervention: Control Arm
Standard of care as per guidelines of the local centre



Primary Outcome Measures :
  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. [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Patient satisfaction: questionnaire [ Time Frame: 1 year ]
    Patient feedback from patient satisfaction questionnaire, at baseline, and all follow-up visits to the end of the study.

  2. Certainty of diagnosis [ Time Frame: 1 year ]
    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.

  3. Frequency of diagnosis [ Time Frame: 1 year ]
    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.

  4. Time to diagnosis [ Time Frame: 1 year ]
    Time from randomisation to diagnosis by the physician, as recorded at final follow-up visit.

  5. Measure resource use [ Time Frame: 1 year ]
    Rates of liver related outpatient investigations/consultations/hospital admissions per 400 patients during the study.

  6. Cost effectiveness of LiverMultiScan [ Time Frame: 1 year ]
    Cost of LiverMultiScan based on randomised comparison.

  7. Personnel skills required for diagnosis [ Time Frame: 1 year ]
    Percentage of total consultations performed by a specialist, at each specialist medical category, from date of randomisation to end of study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289897


Contacts
Layout table for location contacts
Contact: Laura Herdman, BSc 00441865655343 radical@perspectum.com

Locations
Layout table for location information
Germany
University Hospital Ulm Recruiting
Ulm, Baden-Württemberg, Germany, 89081
Contact: Laura Herdman, BSc    00441865655343    radical@perspectum.com   
Principal Investigator: Matthias Dollinger         
Netherlands
Leiden University Medical Center Recruiting
Leiden, South Holland, Netherlands, 2333
Contact: Laura Herdman, BSc    00441865655343    radical@perspectum.com   
Principal Investigator: Minneke Coenraad         
Portugal
University of Coimbra Recruiting
Coimbra, Centro, Portugal, 3004-531
Contact: Laura Herdman, BSc    00441865655343    radical@perspectum.com   
Principal Investigator: Miguel Castelo Branco         
United Kingdom
Southampton University Hospital Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Laura Herdman    00441865665343    radical@perspectum.com   
Principal Investigator: Chris Byrne         
Aintree Hospital Recruiting
Liverpool, Merseyside, United Kingdom, L9 7AL
Contact: Laura Herdman, BSc    00441865665343    radical@perspectum.com   
Principal Investigator: Dan Cuthbertson         
Ninewells Hospital Recruiting
Dundee, United Kingdom, DD2 1SG
Contact: Laura Herdman, BSc    00441865655343    radical@perspectum.com   
Principal Investigator: Michael Miller         
Royal Infirmary of Edinburgh Active, not recruiting
Edinburgh, United Kingdom, EH16 4SA
Glasgow Royal Infirmary Recruiting
Glasgow, United Kingdom, G40SF
Contact: Laura Herdman, BSc    00441865655343    radical@perspectum.com   
Principal Investigator: Stephen Barclay         
Queen Elizabeth University Hospital Recruiting
Glasgow, United Kingdom, G51 4TF
Contact: Laura Herdman, BSc    00441865655343    radical@perspectum.com   
Principal Investigator: Andrew Fraser         
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: Laura Herdman, BSc    00441865665343    radical@perspectum.com   
Principal Investigator: Kosh Agarwal         
St George's Hospital Recruiting
London, United Kingdom, SW170Q2
Contact: Laura Hedrman, BSc    00441865665343    radical@perspectum.com   
Principal Investigator: Daniel Forton         
Sponsors and Collaborators
Perspectum Diagnostics Ltd
University of Coimbra
University Hospital Ulm
Leiden University Medical Center
Liverpool University Hospitals NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
King's College Hospital NHS Trust
NHS Greater Glasgow and Clyde
Glasgow Royal Infirmary
Ninewells Hospital
Royal Infirmary of Edinburgh
St George's University Hospitals NHS Foundation Trust
Investigators
Layout table for investigator information
Principal Investigator: Matthias Dollinger, MD University Hospital Ulm
Principal Investigator: Dimitar Tonev, MD Perspectum Diagnostics
Publications:
Layout table for additonal information
Responsible Party: Perspectum Diagnostics Ltd
ClinicalTrials.gov Identifier: NCT03289897    
Other Study ID Numbers: PJM124
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatty Liver
Non-alcoholic Fatty Liver Disease
Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Liver Diseases
Digestive System Diseases