Identifying Probable Non-alcoholic Steatohepatitis using Imaging V1.0
Research type
Research Study
Full title
A pilot study to identify probable nonalcoholic steatohepatitis (NASH) using transient elastography and Magnetic Resonance Imaging scan for LiverMultiScan
IRAS ID
300285
Contact name
Heather Bryson
Contact email
Sponsor organisation
Synexus Clinical Research Ltd
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
The study aims to investigate whether the combination of two non-invasive liver imaging tests (Fibroscan and LiverMultiScan) can assist in improving the accurate identification of individuals with probable non-alcoholic steatohepatitis (NASH) which in turn will assist in identifying the most suitable individuals for participation in NASH studies. This is of relevance as it avoids unnecessary exposure to procedures such as liver biopsy and provides an earlier and more convenient means of intervening to optimize patient care. Participation is voluntary and directed at adults 45-80 years old with increased risk of NASH due to T2DM and additional metabolic risk factors. Study will be conducted at approximately 6 Synexus dedicated research sites in England. Synexus Clinical Research Ltd. will provide the funding. The estimated total duration of participation is one to two months. Up to 30 participants will be included. Recruitment will take place via multiple channels including social media, community advertisements and GP referrals. Interested participants will be scheduled for remote screening visits with a research professional to determine eligibility. If eligible, participant will be scheduled for an on-site visit and provide consent for record retrieval. Once on-site the participant will discuss and sign study informed consent and undergo a Fibroscan and blood draw. On the basis of the results the participant will be assessed as low, intermediate or high-risk for NASH. Those in the high-risk category will be offered direct screening to a NASH study while those in the low-risk category will be excluded from further investigation. Those in the intermediate-risk category will undergo LiverMultiScan. The LiverMultiScan results will be combined with AST and fasting glucose into a score that will distinguish low- and high-risk groups. Participants from the high-risk group will be offered participation in a NASH study. Those in the low-risk group will be excluded from further investigation.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
21/EM/0138
Date of REC Opinion
12 Aug 2021
REC opinion
Further Information Favourable Opinion