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Trial record 1 of 1 for:    NCT03289897
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Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan (RADIcAL1)

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ClinicalTrials.gov Identifier: NCT03289897
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborators:
University of Oxford
Leiden University Medical Centre, DEPT of Parasitology, Leiden Holland
University of Coimbra
University of Ulm
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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 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 : September 4, 2019
Estimated Study Completion Date : February 28, 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. Measuring the cost effectiveness of LiverMultiScan (LMS) as a standardised diagnostic test for liver disease in different EU territories [ Time Frame: 1 year ]
    To investigate whether the introduction of LiverMultiScan as a standardised diagnostic test for liver disease can prove a cost-effective method by reducing the number of patients with suspected NAFLD who incur liver-related hospital consultations, including liver biopsies. In this study there are 1000 patients in the study arm (LiverMultiScan) and 1000 patients in the standard arm (normal Pathway). The data will be analysed to assess LMS cost effectiveness.


Secondary Outcome Measures :
  1. Improvement in patient satisfaction with the new technology compare to current care pathway. [ Time Frame: The time points at which the patients' feedback on their health using the EQ-5D-5L questionnaire will be assessed are at randomisation, at 2 months, at 6 months and at 1 year. ]
    To investigate patient feedback on their health by using EQ-5D-5L questionnaire. Participants will provide feedback on their health using the questionnaire at randomisation, 2 months, 6 months and 12 months. The data provided will be entered into the central database and will be analysed by the Clinical Trial Units, Leiden.



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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


Locations
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Germany
Prof Dr. Matthias Dollinger Recruiting
Ulm, Baden-Württemberg, Germany, 89081
Contact: Soubera Rymell, Bsc    00441865655327    soubera.rymell@perspectum-diagnostics.com   
Contact: Neelam Hassanali, DPhil    00441865655327    neelam.hassanali@perspectum-diagnostics.com   
Netherlands
Dr Minneke Coenraad Recruiting
Leiden, South Holland, Netherlands, 2333
Contact: Soubera Rymell, BSc    00441865655327    soubera.rymell@perspectum-diagnostics.com   
Contact: Neelam Hassanali, DPhil    00441865655327    neelam.hassanali@peerspectum-diagnostics.com   
Portugal
Dr Miguel Castelo Branco Recruiting
Coimbra, Centro, Portugal, 3004-531
Contact: Soubera Rymell, BSc    00441865655327    soubera.rymell@perspectum-diagnostics.com   
Contact: Neelam Hassanali, DPhil    00441865655327    neelam.hassanali@perspectum-diagnostics.com   
Sponsors and Collaborators
Perspectum Diagnostics Ltd
University of Oxford
Leiden University Medical Centre, DEPT of Parasitology, Leiden Holland
University of Coimbra
University of Ulm

Publications:
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Responsible Party: Perspectum Diagnostics Ltd
ClinicalTrials.gov Identifier: NCT03289897     History of Changes
Other Study ID Numbers: PJM124
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases