Status:
COMPLETED
Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan
Lead Sponsor:
Perspectum
Collaborating Sponsors:
University of Coimbra
University Hospital Ulm
Conditions:
NASH - Nonalcoholic Steatohepatitis
NAFLD
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
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 diseas...
Eligibility Criteria
Inclusion
- 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:
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
801 Patients enrolled
Trial Details
Trial ID
NCT03289897
Start Date
September 5 2017
End Date
December 31 2020
Last Update
August 22 2023
Active Locations (11)
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1
University Hospital Ulm
Ulm, Baden-Wurttemberg, Germany, 89081
2
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333
3
University of Coimbra
Coimbra, Centro, Portugal, 3004-531
4
Southampton University Hospital
Southampton, Hampshire, United Kingdom, SO16 6YD