An interventional study of LiverMultiScan in NASH - Nonalcoholic Steatohepatitis, NAFLD and Metabolic Syndrome, sponsored by Perspectum. Completed at 11 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-22.
Sponsored by Perspectum · Not applicable, Interventional, and Other
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.
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.
Presence of:
OR
OR
Presence of ≥ 3 of the following criteria:
low HDL-cholesterol (\< 1.05 mmol/l for men / \< 1.25 mmol/l for women)
Exclusion Criteria:
Patients will be scanned using the LiverMultiScan. Follow-up will be determined by the results of the scan.
Diagnostic Test: LiverMultiScan
Standard of care as per guidelines of the local centre
LiverMultiScan is an imaging technique which is able to identify early liver disease.
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.
Time frame: 1 year
Patient satisfaction: questionnaire
Patient feedback from patient satisfaction questionnaire, at baseline, and all follow-up visits to the end of the study.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
Time to diagnosis
Time from randomisation to diagnosis by the physician, as recorded at final follow-up visit.
Time frame: 1 year
Measure resource use
Rates of liver related outpatient investigations/consultations/hospital admissions per 400 patients during the study.
Time frame: 1 year
Cost effectiveness of LiverMultiScan
Cost of LiverMultiScan based on randomised comparison.
Time frame: 1 year
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.
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Perspectum