NASH - Nonalcoholic SteatohepatitisRADIcAL1NCT03289897
Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan
A study testing LiverMultiScan in people with NASH - Nonalcoholic Steatohepatitis and NAFLD, run by Perspectum at 11 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis, NAFLD, Metabolic Syndrome
- What is being tested?
- LiverMultiScan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 801 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 5 Sep 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United Kingdom8 sites
Ninewells Hospital
Dundee, DD2 1SG
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Glasgow Royal Infirmary
Glasgow, G40SF
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Aintree Hospital
Liverpool, Merseyside, L9 7AL
King's College Hospital
London, SE5 9RS
St George's Hospital
London, SW170Q2
Southampton University Hospital
Southampton, Hampshire, SO16 6YD
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333
About this study
Official title: Non-invasive Rapid Assessment of Non-alcoholic Fatty Liver Disease (NAFLD) Using Magnetic Resonance Imaging With LiverMultiScan (RADIcAL1)
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.
Read the 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.
- Being tested
- LiverMultiScan
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiverMultiScanDiagnostic test
LiverMultiScan is an imaging technique which is able to identify early liver disease.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm-LiverMultiScan | Experimental | Patients will be scanned using the LiverMultiScan. Follow-up will be determined by the results of the scan. Receives: Diagnostic Test: LiverMultiScan |
| Control Arm | No intervention | Standard of care as per guidelines of the local centre |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (7)
Patient satisfaction: questionnaire
Patient feedback from patient satisfaction questionnaire, at baseline, and all follow-up visits to the end of the study.
Measured: 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.
Measured: 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.
Measured: 1 year
Time to diagnosis
Time from randomisation to diagnosis by the physician, as recorded at final follow-up visit.
Measured: 1 year
Measure resource use
Rates of liver related outpatient investigations/consultations/hospital admissions per 400 patients during the study.
Measured: 1 year
Cost effectiveness of LiverMultiScan
Cost of LiverMultiScan based on randomised comparison.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start5 Sep 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 801 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perspectum
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Responsible party
- Sponsor
- Investigators
- Matthias Dollinger, MD, Principal investigator, University Hospital UlmDimitar Tonev, MD, Principal investigator, Perspectum Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289897
- Sponsor's protocol ID
- PJM124
- Acronym
- RADIcAL1
- Status last verified
- Aug 2023
- First submitted
- 5 Sep 2017
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24036007Pavlides 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.
PubMed 26471505Tonev 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.
PubMed 33104014
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Rapid Assessment of Non-alcoholic Fatty Liver Disease (NAFLD) Using Magnetic Resonance Imaging With LiverMultiScan (RADIcAL1)
- ClinicalTrials.gov ID
- NCT03289897
- Acronym / sponsor ID
- RADIcAL1 / PJM124
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 801 participants (actual)
- Lead sponsor
- PerspectumIndustry (pharma, biotech, devices)
- 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
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 21 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Arm-LiverMultiScan | Experimental | Diagnostic Test: LiverMultiScanPatients will be scanned using the LiverMultiScan. Follow-up will be determined by the results of the scan. |
| Control Arm | No intervention | –Standard of care as per guidelines of the local centre |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male and female patients aged 18-75 years, due to undergo evaluation for suspected non-alcoholic fatty liver disease
- Presence of:
- OR
- imaging suggestive of Fatty liver disease.
- OR
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiverMultiScanLiverMultiScan is an imaging technique which is able to identify early liver disease. | Diagnostic test | Study Arm-LiverMultiScan |
Primary outcome
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.
7 secondary outcomes
Patient satisfaction: questionnaire
Time frame: 1 year
Certainty of diagnosis
Time frame: 1 year
Frequency of diagnosis
Time frame: 1 year
Time to diagnosis
Time frame: 1 year
Measure resource use
Time frame: 1 year
Cost effectiveness of LiverMultiScan
Time frame: 1 year
Personnel skills required for diagnosis
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Background: PubMed 24036007Banerjee 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.
- Background: PubMed 26471505Pavlides 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.
- Derived from this study: PubMed 33104014Tonev 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Dollinger, MD principal investigator
University Hospital Ulm
Dimitar Tonev, MD principal investigator
Perspectum Diagnostics
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiverMultiScan in people with NASH - Nonalcoholic Steatohepatitis and NAFLD, run by Perspectum at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom, Germany, Netherlands, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03289897, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.