A study looking at using biomarkers and MRI scans to spot liver cancer early (SELiNa)
Cancer type:
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This study is looking at blood samples and MRI scans to pick up liver cancer earlier.
It is for people with a type of liver cancer called hepatocellular carcinoma.
The study is part of a larger research programme called DeLIVER that is looking at improving the diagnosis of liver cancer.
More about this trial
Hepatocellular carcinoma (HCC) is the main type of cancer that starts in the liver. People with scarring of the liver from long term damage (
) have an increased risk of developing HCC.
People with cirrhosis usually have regular of the liver and blood tests. This aims to try to pick up cancer in its early stages.
Sometimes the scans don’t detect liver cancer at an early stage. This means cancer is being diagnosed later when it causes symptoms. More advanced cancer is more difficult to treat.
Doctors would like to improve the diagnosis of HCC in people with cirrhosis. They are doing this study to try and find ways of finding liver cancer earlier. Early diagnosis means treatment is more likely to be successful.
The aims of the study are to:
- find new blood
biomarkers to try and spot HCC at an early stage - find out if using MRI scans will make it easier to diagnose HCC earlier
Please note - you won’t directly benefit from taking part in this study. Taking part will not change your treatment.
Who can enter
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
- have early stage hepatocellular carcinoma (HCC). This means you have up to 3
nodules on your liver, which are all less than 3cm across and your liver is working well. If you have scarring of your liver (cirrhosis ) this can be from any cause. You might be able to take part if you don’t have cirrhosis. - have had a
biopsy which shows you have HCC if you don’t have cirrhosis - have been diagnosed in the 3 months before joining the study. You might be able to take part if you had HCC that was removed with heat (ablation) or surgery more than 6 months ago and you have a new diagnosis of HCC. This must be in a different part of the liver.
- are at least 18 years old
Who can’t take part
You cannot join this study if any of these apply. You:
- have had a liver transplant. You might be able to take part if you are on the transplant waiting list.
- are taking part in the Pearl study
- have had treatment for HCC in the 3 months before joining the study. This includes surgery, heat treatments (ablation), transarterial chemoembolisation,
internal or external radiotherapy , chemotherapy or immunotherapy
There are also separate entry conditions for the MRI part of the SELiNa study.
As well as the above, you can’t take part in the MRI study if any of these apply. You:
- are not able to safely have an MRI scan. Reasons for this include being afraid of small spaces (claustrophobia), pregnancy or having metal anywhere in your body
- are not able to spend up to 75 minutes in the MRI scanner
Trial design
This study is taking place in the UK. The study team need 200 people with cirrhosis and 50 people without cirrhosis to take part.
Everyone taking part has hepatocellular carcinoma.
Baseline and 1 year visit
When you join the study, you have blood tests, and you give a urine sample. One year later, you have a further blood test, and you give another urine sample. You have these at the same time as routine hospital visits where possible. Each time it will take an extra 30 to 45 minutes on top of your routine appointment.
The team plan to use the samples to:
- look for
biomarkers in the blood and urine which could help diagnose HCC earlier - learn more about HCC and why it develops
- find out more about why treatment works better for some people than for others
The study team will also collect information from your medical notes. This includes information about:
- your height and weight
scan results
Follow up
The team then contact you once a year for up to 3 years. They could be in touch with you:
- over the phone
- by email - you fill in a questionnaire and email it back to them
- in person - if you have a routine appointment booked
This is to find out how you’ve been getting on and if anything has changed with your health. This takes about 35 minutes.
The team also look at your medical records to see if there have been any changes.
Long term follow up
The team look at your medical records and medical information from NHS England. They also look at other patient registries such as the
They collect the results of tests and scans and any treatment you may have had.
They do this for at least 10 years after you have finished taking part in the study.
Samples for research
The team will ask to store any remaining blood samples for future research. You don’t have to agree to this. You can still take part in the study.
The team will ask to look at any liver tissue from any you may have as part of your routine care. The researchers aim to look for biomarkers which could be used for finding cancer early in the future. You don’t have to agree to this. You can still take part in the study.
MRI substudy
The study team would like to look at MRI scans and Magnetic Resonance Elastography (MRE) scans for HCC. This is called the MRI substudy.
Having an MRE is similar to having an MRI scan. But for the MRE scan, your team put a small plastic disc over your tummy (abdomen) where your liver is. You might feel this vibrate while you have your scan.
Both scans are a way of producing detailed images of the liver. The study team would like to use the scan results to learn more about diagnosing HCC.
Taking part in the MRI substudy is optional. You can say no and still take part in the main study. Some people may have to travel to a different hospital to have the scans.
You have both scans one after the other, and it takes around 90 minutes in total. You have one scan visit when you join the study. And a second scan around a year later.
You have no food or drink for 4 hours before your scans.
Hospital visits
The study team aim for you to have any visits or tests at the same time as your routine care.
You have 2 extra hospital visits if you take part in the MRI substudy. The study team can give you more detail about this.
Side effects
There are no side effects apart from some possible slight bleeding or bruising from the blood samples.
An MRI scan is a safe test and does not use radiation. We have more information on having an MRI scan including possible risks.
There are no extra risks from having an MRE scan.
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Eleanor Barnes
Supported by
Cancer Research UK
University of Oxford
Other information
The study is part of a larger research programme called DeLIVER that is looking at improving the diagnosis of liver cancer. Other studies that are part of this programme are:
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
