At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- non contrast enhanced MRI (diagnostic test)
- How long the study runs
- Study runs about 167 months (dates as stated)
- About the drug or intervention
- non contrast enhanced MRI — diagnostic test: 6 monthly non contrast enhance MRI
- Patient visit burden
- "Study participants will have an ultrasound scan every 6 months as they would in their standard clinical care and an additional 6 monthly non-contrast MRI scan for 30 months (6 visits)." (as stated by sponsor)
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 300
- Started
- 2025-05-01
- Last checked
- 2025-09
Plain English Summary
What is this study?
- • Testing a new treatment for cirrhosis
- • Clinical study - 300 participants
- • Aim: To use magnetic resonance imaging (MRI) scans without contrast to help improve diagnosis of liver cancer in people who are at increased risk of developing liver cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with cirrhosis
Where?
- • Oxford - Oxford University Hospitals NHS Foundation Trudt
- • Bournemouth - Bournemouth University Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Aim: To use magnetic resonance imaging (MRI) scans without contrast to help improve diagnosis of liver cancer in people who are at increased risk of developing liver cancer. Background: People with any condition that affects the liver over a long period of time can develop cirrhosis. Conditions and risk factors that can lead to cirrhosis include alcohol excess, liver steatosis (lipid or fat accumulation in the liver) and infection with the viruses hepatitis B and C. One of the concerns about people with cirrhosis is that they are at increased risk of developing liver cancer. People with cirrhosis are recommended to have an ultrasound scan (USS) every 6 months (surveillance for liver cancer) so that if a cancer develops, it is diagnosed at an early stage when it can be cured. However, ultrasound can miss cancers even in people having scans every 6 months. Furthermore, the risk of cancer is not alike among people with cirrhosis. For example, people with more advanced cirrhosis and those with cirrhosis from hepatitis B are at higher risk. It is therefore possible that better tests than ultrasound are needed for people with cirrhosis who are at particularly high risk of developing cancer. Computed tomography (CT) and Magnetic Resonance Imaging (MRI) scans with dye injection (contrast) are used for liver cancer diagnosis. However, they cannot be done every 6 months because of costs, capacity and toxicity from high CT radiation doses, and MRI contrast build-up in the brain with repeated MRI contrast injections. MRI scans without contrast are not toxic, could be done in 20 minutes and are cheaper, so could be done every 6 months. In the experience of the study investigators, MRI without contrast may raise suspicion of liver cancer in cases missed by ultrasound, so it could be used for surveillance instead of ultrasound. This study aims to find out if it is feasible to use a quick MRI (20 minutes) without contrast as surveillance for liver cancer in people at high risk of liver cancer due to liver cirrhosis and to compare this MRI with ultrasound. Design and Methods: The investigators will recruit 300 people at higher risk of developing liver cancer because of cirrhosis. Study participants will have an ultrasound scan every 6 months as they would in their standard clinical care and an additional 6 monthly non-contrast MRI scan for 30 months (6 visits). If the ultrasound or non-contrast MRI raises concern for a possible liver cancer, an MRI scan with contrast (with dye injection) will be done for definitive diagnosis. All participants will have an MRI with contrast at the end of 30 months (M30) to ensure that no cancers were missed. Participants will be asked to complete questionnaires to measure quality of life, anxiety, and their experience of MRI and ultrasound scans and data will be collected from their medical notes. The number of liver cancers detected by ultrasound will be compared to the number detected by the non-contrast MRI scans.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓• Participant is willing and able to give agreement to take part for participation in the study AND
- ✓All genders, aged 18 years or above AND
- ✓Eligible for HCC US surveillance in the opinion of the local investigators AND
- ✓Child Pugh score A or B AND
- ✓Diagnosed with liver cirrhosis due to ArLD, MASLD, chronic hepatitis C, chronic hepatitis B, genetic...
Who cannot take part
- ✗• safety concern to MRI
- ✗Known allergy / reaction to intravenous gadolinium contrast
- ✗Prisoners
- ✗Pregnancy or breast feeding
- ✗Previous liver transplant
See the full criteria
Where Is This Study? (2 UK sites)
Oxford University Hospitals NHS Foundation Trudt
Oxford ox3 9du, United Kingdom
Bournemouth University Hospital
Bournemouth, United Kingdom
Research Development & Support
clinicalresearch@bournemouth.ac.uk01202 961200How to Get in Touch
Michael Pavlides, DPhil
Sponsor contactCONTACT