Active not recruitingOBSERVATIONAL

LITMUS Imaging Study

The LITMUS Imaging Study is an important research project for people with non-alcoholic fatty liver disease (NAFLD). Instead of only relying on liver biopsies, which can be uncomfortable, this study explores whether clever new scanning techniques, like certain types of ultrasound and MRI scans, can accurately tell us about the health of your liver. Researchers want to compare these advanced scans to biopsy results and also see how NAFLD changes over a couple of years. This could help doctors in the future understand your liver health better and more easily, without needing as many biopsies.

At a glance

Status

Active not recruiting

Sponsor

University of Oxford

Enrolment target

450

Start

04 Sep 2019

Estimated completion

31 Oct 2025

NAFLD NASH NASH - Nonalcoholic Steatohepatitis Fibrosis, Liver Steatosis of Liver

What is this study about?

The LITMUS Imaging Study is looking for better ways to understand and monitor a common liver condition called non-alcoholic fatty liver disease (NAFLD). This condition means there is too much fat in the liver. Sometimes, this can lead to a more serious problem called NASH (non-alcoholic steatohepatitis), which causes inflammation and liver damage, similar to hepatitis. In the long run, this damage can lead to scarring, called fibrosis, which can affect how well the liver works.

Currently, one of the most accurate ways to check for liver damage and NASH is through a liver biopsy, where a small piece of liver tissue is removed and examined. While very informative, biopsies can be uncomfortable and carry some risks. This study aims to find out if special types of scans, like advanced ultrasound and MRI scans, can provide the same important information about your liver health, but in a much simpler and less invasive way. This could mean fewer biopsies are needed in the future.

Researchers will compare the results from these new scans with information from liver biopsies that participants have already had. They will also follow participants for about two years to see if these scans can show how the liver changes over time. By doing this, they hope to improve how doctors diagnose and track NAFLD and NASH, making it easier and more comfortable for patients.

Key takeaways

The study explores new scanning methods for fatty liver disease (NAFLD).
It aims to reduce the need for liver biopsies in the future.
You will have advanced ultrasound and MRI scans.
Participation involves two visits for scans over two years.
This study could improve how doctors monitor liver health.

Who may be eligible?

To join this study, you must already be part of a larger research project called the European NAFLD Registry. Importantly, you would need to have had a liver biopsy recently (in the last 3 months) or be scheduled to have one very soon to check for fatty liver disease (NAFLD).

You also need to be able to understand the study information and give your permission to take part. This includes being able to communicate in the language the study materials are written in, as this is important for your safety, especially regarding the MRI scans.

Unfortunately, if you have certain medical devices in your body like some types of pacemakers or metal implants, or if you are pregnant, you might not be able to have an MRI scan, which means you wouldn't be able to join this study. The study team will make sure it's safe for you to participate.

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 already part of the European NAFLD Registry?
Have you had a liver biopsy for NAFLD recently (within 3 months) or are you having one soon?
Are you aged between 18 and 100 years?
Can you understand information in English (or the study's language) and safely have an MRI scan?
Do you not have any metal implants or conditions that make MRI unsafe?
Are you willing and able to attend two scan appointments over two years?

Answer every question to see your result.

What does participation involve?

If you join the LITMUS Imaging Study, you will have two visits for scans over about two years. The first set of scans will happen within about 100 days (just over 3 months) of your initial liver biopsy. You won't need another biopsy for the study. Then, about two years after your first scans, you'll have a second set of scans.

These scans include different types of advanced ultrasound and MRI scans. The MRI scans are very detailed and look at different aspects of your liver, including fat content and stiffness. There are several different MRI techniques involved to get a full picture. All the information from your scans will be sent securely to specialist centres for analysis. There are no medications involved in this study, only these imaging assessments.

Potential risks and benefits

Taking part in this study may help us learn more about fatty liver disease, which could lead to better ways for doctors to understand and treat it in the future. You will receive detailed information about your liver through advanced scans. The main risks are associated with the MRI scans, which are generally safe but cannot be done if you have certain metal implants or are pregnant. The study team will carefully check if an MRI is safe for you. You are free to stop participating in the study at any time without giving a reason, and this will not affect your medical care.

Locations (18)

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

Pinnacle Clinical Research
Verified postcode
San Antonio, United States
Helsinki University Hospital
Verified postcode
Helsinki, Finland
Le Centre de Recherche Clinique (CRC) du CHU d'Angers
Verified postcode
Angers, France
Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière
Verified postcode
Paris, France
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz
Verified postcode
Mainz, Germany
Universitätsklinikums Würzburg
Verified postcode
Würzburg, Germany
Laiko General Hospital of Athens
Verified postcode
Athens, Greece
Università di Palermo
Verified postcode
Palermo, Italy
Department of Medical Sciences University of Torino
Verified postcode
Torino, Italy
Vall d'Hebron University Hospital
Verified postcode
Barcelona, Spain
Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital
Verified postcode
Seville, Spain
HU Clínico de Valladolid
Verified postcode
Valladolid, Spain

Common questions

What is NAFLD?

NAFLD stands for non-alcoholic fatty liver disease, meaning there's too much fat in your liver not caused by alcohol.

What is NASH?

NASH is a more serious type of NAFLD where the liver is inflamed and damaged, similar to hepatitis.

What scans will I have?

You'll have special ultrasound and MRI scans, which are non-invasive ways to look at your liver health.

Do I need more biopsies?

No, you don't need any extra biopsies for this study. It uses information from a biopsy you've already had or are about to have.

How long does the study last?

Your involvement in the study will be for about two years, with two sets of scans during that time.