The Liver FAPI Fibrosis Study (v1.0 09Mar23)
Research type
Research Study
Full title
Investigation of FAPI PET-MR for the study of fibrosis in chronic liver disease
IRAS ID
315436
Contact name
Neil Henderson
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
5 years, 0 months, 0 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 68Ga-FAPI radiotracer (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 non-alcoholic steatohepatitis and primary sclerosing cholangitis.
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 a PET-MR scan and will have further blood samples taken at their 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 Queens’s Medical Research Institute (University of Edinburgh).
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
23/EE/0085
Date of REC Opinion
21 Apr 2023
REC opinion
Favourable Opinion