TAEUS-NAFLD
Research type
Research Study
Full title
Feasibility Study Quantifying Fatty Liver Using Thermoacoustic Imaging
IRAS ID
292441
Contact name
Ashley Barnabas
Contact email
Sponsor organisation
King's College Hospital
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Non-alcoholic fatty liver disease (NAFLD) and Non-alcoholic steatohepatitis (NASH) now affects 1 billion people globally, with 30 million new NAFLD-NASH cases per year. The global prevalence of NAFLD is 24%, and it is expected that NASH will increase by 63% between 2015 and 2030 as a result of rising levels of obesity. NAFLD and its inflammatory form, NASH, are the results of an unhealthy accumulation of fat in the liver. Excess liver fat can lead to liver inflammation, fibrosis, cirrhosis and even hepatocellular carcinoma (HCC). Cirrhosis causes irreversible damage to the liver and is the most severe stage of NAFLD.
To date there are no FDA approved drugs for treatment of NAFLD. The current ‘gold standard’ for measuring NAFLD-NASH and advanced liver disease (such as fibrosis, cirrhosis and cancer) is by undertaking a liver biopsy. However, a biopsy is an invasive surgical procedure with potential risks which makes it impractical for everyday clinical practice. There is urgent need to identify non or minimally invasive diagnostic tools for early detection of NASH or NAFLD.
This project aims to assess the efficacy of the TAEUS FLIP probe during ultrasound, produced by Endra Life Sciences, in comparison to a quantitative MRI scan. The probe’s primary function is to measure fat content, which may support clinician’s in their diagnosis of non-alcoholic fatty liver disease. Eligible and willing patients attending outpatient clinics at King’s College Hospital will be asked to undertake an MRI-PDFF scan and an ultrasound (using the TAEUS FLIP probe). The results of this project will be used to determine whether the use of this novel device is a viable alternative diagnostic tool in comparison to an MRI.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
21/NE/0171
Date of REC Opinion
16 Sep 2021
REC opinion
Unfavourable Opinion