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

Phase 4

Completed

• Conditions: fatty liver; Non-alcoholic fatty liver disease; 10019654; 10000546

• Registration Number: NL-OMON50322
• Lead Sponsor: Perspectum Diagnostics

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-12-31
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 177

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 (< 1.05 mmol/l for men / < 1.25 mmol/l for women)

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome *proportion of patients with suspected NAFLD incurring liver<br /><br>related hospital consultations and/or liver biopsies</p><br>

Secondary Outcome Measures

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