RADIcAL 1
Research type
Research Study
Full title
Non-invasive rapid assessment of non-alcoholic fatty liver disease (NAFLD) using Magnetic Resonance Imaging with LiverMultiScan (RADIcAL)
IRAS ID
244088
Contact name
Dimitar Tonev
Contact email
Sponsor organisation
Perspectum Diagnostics Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The current standard for diagnosing and staging NASH is a liver biopsy,which is costly, invasive and carries risk for the patient. LiverMultiScan™ (LMS) uses multiparametric MRI to characterise liver tissue to aid the diagnosis of liver disorders. RADIcAL1 is a randomised control trial (RCT) to determine cost-effectiveness of LMS versus the existing standard care pathway for assessing chronic liver disease in tertiary-referral hepatology centres across Europe.
RADIcAL1 will recruit 2000 patients suspected of NAFLD/NASH from centres across Europe. Eligible participants will be screened and randomised (1:1) to either the current diagnostic evaluation (control arm), or LMS (study arm). Participants in the study arms with a corrected T1 of <800 ms and proton density fat fraction <10%, will be managed in primary care. Those not meeting these criteria will be recommended for further diagnostic evaluation. The primary outcome will be the proportion of patients receiving liver-related hospital consultations and/or biopsies in each arm. Healthcare costs will also be compared between arms following the intention-to-treat principle.REC name
South Central - Berkshire Research Ethics Committee
REC reference
18/SC/0275
Date of REC Opinion
25 May 2018
REC opinion
Favourable Opinion