The MASLD FAPI Fibrosis Study
Research type
Research Study
Full title
Investigation of FAPI PET-MR for the study of fibrosis in metabolic dysfunction-associated steatotic liver disease
IRAS ID
344461
Contact name
Neil Henderson
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Chronic liver disease affects approximately 844 million people worldwide and is becoming increasingly common. Repeated liver injury due to any chronic liver disease causes inflammation and subsequent scarring, for which the only treatment is liver transplantation. Consequently, approximately two million people worldwide die of chronic liver disease each year.
This study will use FAPI radiotracers (a colourless liquid injected into the blood) combined with state-of-the-art hybrid positron emission tomography and magnetic resonance (PET-MR) imaging to evaluate active fibrosis happening in the liver. The FAPI radiotracer will bind to areas of active fibrosis, which can then be detected on the
scanning images. This will allow us to explore whether fibrosis activity is increased compared to healthy volunteers in patients with chronic liver disease, initially focusing on individuals >40 years of age with metabolic dysfunction-associated steatotic liver disease (MASLD).At present the only way to definitively ascertain the degree of scarring within the liver is by performing a biopsy which carries a potential risk to the patient. PET-MR imaging could instead be used to determine this without the potential risks of a biopsy.
The study will last for three years following participant enrolment. All participants will attend a screening visit where personal, demographic and clinical information will be gathered. Participants will also have blood and urine samples taken at that time. They will then be invited back for magnetic resonance elastography (MRE) and PET-MR scan. They will also have further blood samples taken at their PET-MR scan visit. Some participants will be asked to consider having a second scan at a later date, but this is not compulsory in order to partake in this study.
This study is being funded by the Wellcome Trust and conducted between the Royal Infirmary of Edinburgh (NHS Lothian) and the Centre for Inflammation Research (University of Edinburgh).
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
24/EE/0220
Date of REC Opinion
10 Sep 2024
REC opinion
Further Information Favourable Opinion