RecruitingOBSERVATIONAL

The COherence of Scatter Identification and Exclusion Algorithm Study

This study is looking at a common liver condition called non-alcoholic fatty liver disease (NAFLD), which is becoming very widespread. It can also be a side effect of cancer treatments like chemotherapy. Ultrasounds are great for checking for NAFLD because they're affordable and easy to use, but sometimes the results aren't as precise as they could be. Researchers have developed a new computer program, called COSIE, which aims to make ultrasound readings much more reliable. This program helps the ultrasound choose the best parts of the liver to measure. We'll be comparing these improved ultrasound measurements with detailed MRI scans to see if they can become just as accurate.

At a glance

Status

Recruiting

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

Start

27 Aug 2024

Estimated completion

30 Jun 2025

Steatohepatitis, Nonalcoholic

What is this study about?

Non-alcoholic fatty liver disease (NAFLD) is becoming a very common health issue, affecting many people worldwide. It can also develop as an unwanted side effect in people who have had certain cancer treatments, such as chemotherapy. Finding NAFLD early is important, and ultrasound scans are a great tool for this because they are widely available and don't cost a lot of money. However, sometimes the ultrasound measurements can be a bit inconsistent, meaning they might not always give as clear a picture as doctors would like.

To make ultrasound scans more dependable in detecting NAFLD, scientists have created a new computer program called COSIE. This program helps the ultrasound machine focus on the best areas of the liver to get the most accurate measurements. Think of it like making sure the camera focuses on the clearest part of a photograph. This study aims to see if using the COSIE program can make ultrasound results as good as those from MRI scans, which are currently considered the 'gold standard' for measuring liver fat.

Researchers will compare the COSIE-improved ultrasound measurements from healthy volunteers and patients with known fatty liver against their MRI scan results. This comparison will help them understand if COSIE truly improves the reliability of ultrasound, potentially allowing more people to get early and accurate diagnoses of fatty liver disease using a simple and accessible method.

Key takeaways

Aims to improve ultrasound accuracy for fatty liver.
Compares a new computer program (COSIE) to MRI scans.
Could make fatty liver detection easier and cheaper.
Looks at healthy volunteers and patients with fatty liver.
Focuses on non-alcoholic fatty liver, including after cancer treatment.

Who may be eligible?

This study is looking for two groups of people to take part. The first group is healthy adults, aged 18 or over, who work at RMH or ICR and consider themselves fit and well. You should not have any undiagnosed health problems or be planning to see your doctor about a new health concern, especially related to your belly area.

The second group is patients, aged 18 or over, who are already having a liver MRI scan as part of their regular medical care and have shown signs of fatty liver on an earlier MRI. You should not have severe liver scarring (known as fibrosis stage F4 or severe cirrhosis). All participants need to have an NHS number and be registered with a GP in the UK.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have an NHS number and are you registered with a GP?
If healthy, do you work for RMH or ICR and consider yourself fit and well?
If a patient, are you already having a liver MRI as part of your care and have had fatty liver shown on a previous MRI?
If a patient, do you NOT have very severe liver scarring (F4 fibrosis or severe cirrhosis)?

Answer every question to see your result.

What does participation involve?

The detailed involvement for participants isn't fully described in the summary, but it's likely healthy volunteers would have an ultrasound scan and an MRI scan of their liver. Patients would already be having an MRI scan as part of their routine care, and would also have an ultrasound scan. The total duration of participation would depend on scheduling these appointments.

Potential risks and benefits

Potential benefits of taking part include contributing to medical research that could lead to better and more accessible ways of detecting fatty liver disease, potentially improving early diagnosis for many people. The risks associated with ultrasound and MRI scans are generally very low; ultrasounds use sound waves and MRIs use strong magnets and radio waves, neither of which use radiation. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Royal Marsden Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is NAFLD?

NAFLD stands for Non-Alcoholic Fatty Liver Disease. It's a common condition where too much fat builds up in the liver, not caused by drinking a lot of alcohol.

Why is this study important?

This study hopes to make ultrasound scans a more accurate and reliable way to detect fatty liver, which could lead to earlier diagnoses for more people, using a simple and common test.

What is COSIE?

COSIE is a new computer program that helps the ultrasound machine get better, more reliable measurements from the liver during a scan.

Will I have an MRI scan?

Both healthy volunteers and patients involved in the study will have an MRI scan of their liver, as this is used to check the accuracy of the new ultrasound method.

Will taking part affect my regular medical care?

No, taking part in this study will not affect your routine medical care or treatment in any way.

How to find out more

Emma J Harris, PhD

emma.harris@icr.ac.uk +442087224576 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.