CirrhosisAMULETNCT06658782
Abbreviated Magnetic Resonance Imaging vs Ultrasound Surveillance for Liver Cancer dETection in People at High Risk of Developing Liver Cancer
An observational study of Cirrhosis and Cirrhosis Due to Hepatitis B, run by University of Oxford at 2 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Cirrhosis Due to Hepatitis B, Cirrhosis and Chronic Liver Disease
- What is being tested?
- non contrast enhanced MRI
- How many people
- 300 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 May 2025to 30 Apr 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with a high risk of HCC will be included. Participants will have liver cirrhosis from Alcohol related liver disease, metabolic dysfunction associated steatotic liver disease, chronic hepatitis C, chronic hepatitis B or genetic haemochromatosis, or with chronic liver disease and prior successful treatment for HCC without recurrence and who are back in surveillance with USS.
Who may be able to join
- • Participant is willing and able to give informed consent 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 haemochromatosis AND
- Have an annual risk of HCC of at least 3% as determined by the aMAP score OR
- Participants with chronic liver disease (with or without cirrhosis) who had successful treatment for HCC, have not had a recurrence and have returned to 6 monthly surveillance with USS
Who cannot join
- • Contraindication to MRI
- Known allergy / reaction to intravenous gadolinium contrast
- Prisoners
- Pregnancy or breast feeding
- Previous liver transplant
- Participants who are known to have indeterminate liver nodules on prior imaging requiring ongoing follow-up with MRI or CT
Show all 11Show fewer
- Previous HCC treated with curative intent and still being followed up with CT or MRI with contrast for possible recurrence
- Estimated glomerular filtration rate of <30 ml/min/1.73m2
- Participant is on haemodialysis
- Participants who are unlikely to comply with the study procedures in the opinion of the local investigator
- In the view of the clinician, if the participant has a co-morbidity likely to lead to death within the following 12 months
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Bournemouth University Hospital
Bournemouth
- Recruiting
Oxford University Hospitals NHS Foundation Trudt
Oxford, Oxon, ox3 9du
Michael Pavlides, DPhil, michael.pavlides@ouh.nhs.uk
Michael Pavides, DPhil
About this study
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.
Read more
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.
- Conditions
- Cirrhosis, Cirrhosis Due to Hepatitis B, Cirrhosis and Chronic Liver Disease, Cirrhosis Due to Hepatitis C, Cirrhosis of the Liver, Hepatocellular Carcinoma
- Being tested
- non contrast enhanced MRI
- Keywords
- SURVEILANCE, DIAGNOSTIC ACCURACY, abbreviated MRI, no contrast enhanced MRI
- Medical subject headings
- Fibrosis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non contrast enhanced MRIDiagnostic test
6 monthly non contrast enhance MRI
| Study group | Role | What they receive |
|---|---|---|
| non contrast MRI AND standard of care USS | Participants undergo ultrasound every 6 months as per routine clinical care. In addition they undergo research non-contrast enhanced MRI at the same 6 monthly intervals Receives: Diagnostic Test: non contrast enhanced MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance for HCC
True positive tests for HCC per round of surveillance False positive tests for HCC per round of surveillance Positive predictive value for HCC per round of surveillance True negative tests for HCC over the 30 months of surveillance False negative tests for HCC over the 30 months of surveillance Sensitivity and specificity of nceMRI and USS for HCC over 30 months of surveillance
Measured: from enrolment to 30 months
Secondary outcomes (8)
stage and size of HCC at diagnosis
Numbers of HCC detected by nceMRI and USS at a very early, early, intermediate or advanced stage as defined by the Barcelona Clinic Liver Cancer staging system.
The number and size of HCC tumours per participant with HCC The number of new indeterminate lesions identified at each surveillance round
Measured: from enrolment to 30 months
proportion of participants that receive treatment with curative intent
Proportion of participants diagnosed with HCC who go on to receive treatment with curative intent
Measured: from enrolment to 30 months
Quality of Life, Anxiety and Depression
Results of the EQ-5D-5L questionnaire and Hospital Anxiety and Depression Scale questionnaire
Measured: from enrolment to 30 months
participant experience
Results of participant experience questionnaire
Measured: baseline, and month 24
number of unused appointments
We will count how many appointments for HCC surveillance are unused due to appointments that are missed by participants or cancelled buy the health care provider, or due to participants being lost to follow-up or participants where HCC surveillance is no longer indicated.
Measured: from enrolment to 30 months
multivariate models
Sensitivity and specificity of multivariable models for the diagnosis of HCC
Measured: month 30
mechanistic sub-study quantitative MRI metrics
Quantitative variables extracted from MRI data; T1 (ms), R2* (ms), PDFF (%), ADC (mm2/s)
Measured: from baseline to months 30
long term outcomes
A composite end point including the outcomes of: all cause mortality, liver related mortality, liver decompensation (ascites, hepatic encephalopathy, variceal bleeding), hepatocellular cancer, non primary liver cancer, liver transplantation.
Measured: Up to 10 years after the last study MRI scan is performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 May 2025
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Bournemouth University, Glasgow Caledonian University, Nottingham University Hospitals NHS Trust, University of Nottingham
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658782
- Sponsor's protocol ID
- IRAS ID 333813
- Other IDs
- 24/NW/0286
- Acronym
- AMULET
- Status last verified
- Sep 2025
- First submitted
- 16 Oct 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data may be shared with global academic, commercial or other collaborators after analysis and publication of results, which is expected to be after the end of the study.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abbreviated Magnetic Resonance Imaging vs Ultrasound Surveillance for Liver Cancer dETection in People at High Risk of Developing Liver Cancer
- ClinicalTrials.gov ID
- NCT06658782
- Acronym / sponsor ID
- AMULET / IRAS ID 333813
- Conditions
- Cirrhosis, Cirrhosis Due to Hepatitis B, Cirrhosis and Chronic Liver Disease, Cirrhosis Due to Hepatitis C, Cirrhosis of the Liver, Hepatocellular Carcinoma
- Keywords
- SURVEILANCE, DIAGNOSTIC ACCURACY, abbreviated MRI, no contrast enhanced MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Bournemouth University, Glasgow Caledonian University, Nottingham University Hospitals NHS Trust, University of Nottingham
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2039 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non contrast MRI AND standard of care USS | – | Diagnostic Test: non contrast enhanced MRIParticipants undergo ultrasound every 6 months as per routine clinical care. In addition they undergo research non-contrast enhanced MRI at the same 6 monthly intervals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a high risk of HCC will be included. Participants will have liver cirrhosis from Alcohol related liver disease, metabolic dysfunction associated steatotic liver disease, chronic hepatitis C, chronic hepatitis B or genetic haemochromatosis, or with chronic liver disease and prior successful treatment for HCC without recurrence and who are back in surveillance with USS.
Key inclusion criteria (7 listed)
- • Participant is willing and able to give informed consent for participation in the study AND
Key exclusion criteria (11 listed)
- • Contraindication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non contrast enhanced MRI6 monthly non contrast enhance MRI | Diagnostic test | non contrast MRI AND standard of care USS |
Primary outcome
Diagnostic performance for HCC
Time frame: from enrolment to 30 months
True positive tests for HCC per round of surveillance False positive tests for HCC per round of surveillance Positive predictive value for HCC per round of surveillance True negative tests for HCC over the 30 months of surveillance False negative tests for HCC over the 30 months of surveillance Sensitivity and specificity of nceMRI and USS for HCC over 30 months of surveillance
8 secondary outcomes
stage and size of HCC at diagnosis
Time frame: from enrolment to 30 months
proportion of participants that receive treatment with curative intent
Time frame: from enrolment to 30 months
Quality of Life, Anxiety and Depression
Time frame: from enrolment to 30 months
participant experience
Time frame: baseline, and month 24
number of unused appointments
Time frame: from enrolment to 30 months
multivariate models
Time frame: month 30
mechanistic sub-study quantitative MRI metrics
Time frame: from baseline to months 30
long term outcomes
Time frame: Up to 10 years after the last study MRI scan is performed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Yes. Anonymised data may be shared with global academic, commercial or other collaborators after analysis and publication of results, which is expected to be after the end of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Cirrhosis Due to Hepatitis B, run by University of Oxford at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Pavlides, DPhil (+44 1865234577, michael.pavlides@cardiov.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance for HCC (time frame: from enrolment to 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.