PET tracers in patients with MASLD and healthy volunteers (25-501)
Research type
Research Study
Full title
Translational positron emission tomography (PET) imaging of hepatic fibrosis in metabolic dysfunction-associated steatotic liver disease (MASLD): a FIBRE Consortium initiative (25-501)
IRAS ID
366068
Contact name
Hashim Kassim
Contact email
Sponsor organisation
Perceptive
Eudract number
0000-000000-00
ISRCTN Number
ISRCTN80904260
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This is a study of 2 experimental tracers ([68Ga]-CBP8 and [18F]-LNTH-1363S). Tracers are radioactive substances used in positron emission tomography (PET) scans to help take images of areas of the body. The study tracers are being assessed as an experimental new way of diagnosing and monitoring metabolic dysfunction-associated steatotic liver disease (MASLD). We hope that the tracers will work by attaching themselves (‘binding’) to 2 proteins (collagen type I [Col-1] and fibroblast activation-protein [FAP]), which are present in larger quantities in people with MASLD. When the tracer binds, we’ll be able to see its location in the body using a PET scan. We’ll be able to measure the level of Col-1 and FAP within the liver to help with diagnosis and monitoring of MASLD.
In this study, we’ll test single doses the study tracers in patients with MASLD and in healthy volunteers (HV), to find out how much of the tracer gets into the liver, and where is it located in the liver, when given to healthy volunteers compared to patients with MASLD. And to what degree does the amount of tracer in the liver relate to severity of MASLD.
We’ll give 10 participants (5 patients with MASLD [Group 1] and 5 healthy volunteers [Group 2]) aged 23–75 years, single doses of the study tracers at each PET scan. Each participant will have up to 2 PET scans.
Participants in Group 1 will take up to 17 weeks to finish the study. Participants in Group 2 will take up to 13 weeks to finish the study. The study consists of:
• 2 screening visits:
a. Screening visit 1
b. Screening visit 2: participants will undergo a liver MRI to assess eligibility.
• PET imaging session 1 (up to 8 weeks after first screening visit in MASLD patients, up to 4 weeks after first screening visit in HV)
• PET imagining session 2 (7 days to 8 weeks after first imaging session)
• Follow-up phone call (4-7 days after second imaging session)A pharmaceutical company called Perceptive is funding the study.
The study will take place at 1 site and 1 imaging centre in London.
REC name
North East - York Research Ethics Committee
REC reference
26/NE/0021
Date of REC Opinion
16 Mar 2026
REC opinion
Further Information Favourable Opinion