25-501 patients with MASLD, the FIBRE liver imaging study
Currently Recruiting
1 Jun 2026
From £2,700
London, United Kingdom
A study to investigate new methods of diagnosing and monitoring metabolic dysfunction-associated steatotic liver disease (MASLD)
Join our clinical trial
This is a study to assess 2 experimental new 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 tracers in this study will help us take PET images of your liver and are being assessed for their ability to help with the early diagnosis and monitoring of metabolic dysfunction-associated steatotic liver disease (MASLD), previously known as non-alcoholic fatty liver disease (NAFLD). We’re doing this study to find out the amount of tracer that gets into the liver and its location in the liver when taken by healthy participants and patients with MASLD, and to find out if the amount of tracer in the liver correlates to symptoms of MASLD.
Why participate?
If you take part in this trial you’ll be helping medical research – you could help us develop new methods to diagnose and monitor MASLD. In the UK, it’s estimated that up to 20% of people (up to 1 in 5) have fatty liver disease. Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic steatotic fatty liver disease, is a more serious stage of fatty liver disease. MASLD causes liver damage due to a build-up of fat which is stored in the liver, inflammation and liver cell damage. This liver injury can result in the formation of scar tissue, known as fibrosis. MASLD includes a wide range of symptoms that may include fatigue, decreased appetite, nausea, abdominal pain and/or swelling, jaundice (yellowing of the skin and eyes), and dark urine. If it progresses too far without treatment, it can cause severe scarring and liver cancer.
Trial details
Delivery method
On each PET scan day, a trained staff member will put a cannula (a small plastic tube) into a vein in your arm (a vein cannula), which will be used for injecting the radioactive tracer during the PET.
Schedule
The study is scheduled to begin in July 2026. Your participation will involve two initial screening visits, followed by two single-day sessions and one final telephone follow-up. Please note that if there is a gap of more than three months between your two main sessions, an additional outpatient visit may be required.
- During the 8 weeks before you start the study, you’ll have 2 screening visits to see if you’re suitable. At screening visit 2, you’ll have an MRI (magnetic resonance imaging) scan, which uses a strong magnetic field to take pictures of your liver.
- In Session 1, you’ll come in for an outpatient visit, and have 1 PET scan which will use 1 of the study tracers.
- In Session 2, you’ll have 1 PET scan which will use the other study tracer.
- We plan to schedule your study sessions within 1 month of each other. However, the gap between your study sessions may range from 1 week to 6 months.
- If the gap between your study sessions is more than 3 months apart, you’ll come back for an additional outpatient visit before your second study session.
- You’ll receive a telephone call at about 4–7 days after your last study session, for a follow-up.
Inclusion criteria:
You must:
- have MASLD that was diagnosed via a liver biopsy in the last 18 months
- be a man or woman, aged 23 to 75
- have a body mass index (BMI) of 25 or above
- be willing to use contraception
- be registered with a GP (family doctor) in the UK
Exclusion criteria
You must not:
- drink alcohol the day before each visit; you must also not drink more than 2 units of alcohol per day during the study
- use recreational drugs – we’ll test your urine for them
- smoke more than 10 cigarettes, or use a vaping device more than 10 times a day
- be pregnant or breastfeeding
- have donated blood or have taken part in a study of an experimental medicine in the last 3 months, or plan to do so in the 3 months after this study
- have had a serious reaction to any medicine
- have or have had any important illness apart from MASLD (well controlled diabetes might be allowed)
- have a fear or strong dislike of enclosed spaces
- be unable to lie still for very long (for example, you have back pain)
You may not be able to take part if you have certain types of implants or metal in your body, such as a pacemaker, shrapnel, stents or inner ear implants – please tell us if you have any implants or metal in your body.
You may not be able to take part if you’ve been exposed to a lot of radiation in the last 1 year, for example for medical tests, in a clinical trial, or as part of your work.
You may not be able to take part if you’ve recently taken any medicines, including vitamins or herbal remedies like St John’s wort. Please tell us what medicines you’ve taken, and we’ll discuss them with you.
Are you a match?
Age
23 - 75 years old
Study payment
From £2,700
Gender
Male or Female
BMI
BMI from 25 kg/m2
Commitment
2 screening visits, 2 one day-sessions