Metabolic Syndrome Clinical Trial
— RADIcAL1Official title:
Non-invasive Rapid Assessment of Non-alcoholic Fatty Liver Disease (NAFLD) Using Magnetic Resonance Imaging With LiverMultiScan (RADIcAL1)
Verified date | August 2023 |
Source | Perspectum |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 801 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Ulm | Ulm | Baden-Württemberg |
Netherlands | Leiden University Medical Center | Leiden | South Holland |
Portugal | University of Coimbra | Coimbra | Centro |
United Kingdom | Ninewells Hospital | Dundee | |
United Kingdom | Royal Infirmary of Edinburgh | Edinburgh | |
United Kingdom | Glasgow Royal Infirmary | Glasgow | |
United Kingdom | Queen Elizabeth University Hospital | Glasgow | |
United Kingdom | Aintree Hospital | Liverpool | Merseyside |
United Kingdom | King's College Hospital | London | |
United Kingdom | St George's Hospital | London | |
United Kingdom | Southampton University Hospital | Southampton | Hampshire |
Lead Sponsor | Collaborator |
---|---|
Perspectum | Glasgow Royal Infirmary, King's College Hospital NHS Trust, Leiden University Medical Center, Liverpool University Hospitals NHS Foundation Trust, NHS Greater Glasgow and Clyde, Ninewells Hospital, Royal Infirmary of Edinburgh, St George's University Hospitals NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, University Hospital Ulm, University of Coimbra |
Germany, Netherlands, Portugal, United Kingdom,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Patient satisfaction: questionnaire | Patient feedback from patient satisfaction questionnaire, at baseline, and all follow-up visits to the end of the study. | 1 year | |
Secondary | 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. | 1 year | |
Secondary | 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. | 1 year | |
Secondary | Time to diagnosis | Time from randomisation to diagnosis by the physician, as recorded at final follow-up visit. | 1 year | |
Secondary | Measure resource use | Rates of liver related outpatient investigations/consultations/hospital admissions per 400 patients during the study. | 1 year | |
Secondary | Cost effectiveness of LiverMultiScan | Cost of LiverMultiScan based on randomised comparison. | 1 year | |
Secondary | 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. | 1 year |
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