Non-invasive rapid assessment of non-alcoholic fatty liver disease (NAFLD) using Magnetic Resonance Imaging with LiverMultiScan (RADIcAL)

Non-invasive rapid assessment of non-alcoholic fatty liver disease (NAFLD) using Magnetic Resonance Imaging with LiverMultiScan (RADIcAL) - RADIcAL 1 study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50322

Enrollment

200

Registered

2017-07-11

Start date

2017-09-04

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fatty liver Non-alcoholic fatty liver disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Male and female patients aged 18-75, due to undergo evaluation for suspected non-alcoholic fatty liver disease * Participant is willing and able to give informed consent for participation in the study. * Within standard of care presence of: - elevated liver function tests (ALT, AST or GGT * 1.5 x upper limit of normal and ALT, AST * 5 x upper limit of normal) up to 1 year prior to patient recruitment OR - imaging suggestive of Fatty liver disease up to 3 years prior to patient recruitment OR Presence of * 3 of the following criteria at screening:: 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 (

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Primary outcome *proportion of patients with suspected NAFLD incurring liver related hospital consultations and/or liver biopsies	—

Secondary

Measure	Time frame
- Patient feedback from qualitative research using a questionnaire - Clinical outcome measures will be metrics reported by the scan * liver iron, liver fat, cardiovasculaire status and the Liver Inflammation Fibrosis score (cT1 value) * compared to histology and /or non invasive test results in patients in the control arm - Certainty of diagnosis is defined as a binary (yes/no vs. unlikely/probable) and frequency as (yes/probable vs. no/unlikely) - Time from randomisation to diagnosis by the physician. - Rates of consultations, investigations, admissions - Cost-effectiveness of LiverMultiScan based on randomised comparison - Personnel required to perform procedures and tasks	—

Measure

Time frame

- Patient feedback from qualitative research using a questionnaire - Clinical outcome measures will be metrics reported by the scan * liver iron, liver fat, cardiovasculaire status and the Liver Inflammation Fibrosis score (cT1 value) * compared to histology and /or non invasive test results in patients in the control arm - Certainty of diagnosis is defined as a binary (yes/no vs. unlikely/probable) and frequency as (yes/probable vs. no/unlikely) - Time from randomisation to diagnosis by the physician. - Rates of consultations, investigations, admissions - Cost-effectiveness of LiverMultiScan based on randomised comparison - Personnel required to perform procedures and tasks

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Countries

Netherlands

Outcome results