RecruitingOBSERVATIONAL

Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis

This research is looking at new ultrasound scans that could help diagnose a serious liver condition called nonalcoholic steatohepatitis (NASH). NASH is a more advanced form of fatty liver disease and can lead to liver scarring (cirrhosis) and other serious problems if not treated. Currently, the main way to tell how serious NASH is involves a liver biopsy, which is an invasive procedure where a small piece of liver is removed with a needle. This study aims to find out if new, advanced ultrasound techniques can accurately measure liver fat, inflammation, and scarring without needing a biopsy. If successful, these new scans would be much safer and more comfortable for patients.

At a glance

Status

Recruiting

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrolment target

102

Start

23 Oct 2019

Estimated completion

28 Feb 2026

Nonalcoholic Fatty Liver Disease (NAFLD)Nonalcoholic Steatohepatitis (NASH)

What is this study about?

Many people in Western countries have a condition called nonalcoholic fatty liver disease (NAFLD), often linked to things like type 2 diabetes and obesity. A more serious form of this is called nonalcoholic steatohepatitis, or NASH. If NASH isn't caught and managed, it can sadly lead to severe liver damage, including something called cirrhosis. Cirrhosis is a late stage of liver scarring and increases the risk of serious health problems like bleeding, liver cancer, and eventually, liver failure, which might even need a transplant.

Right now, to figure out how severe liver disease is, doctors often need to do a liver biopsy. This involves putting a needle into the liver to take a tiny sample for examination. While necessary in some cases, it's an invasive procedure and carries a small risk of issues like bleeding. It also can sometimes miss things, as it's only looking at a tiny piece of the liver. Because of these challenges, it’s not really suitable for large-scale screening or for people who don't have obvious symptoms.

This study is really important because it's exploring new, gentle ways to check the liver. Researchers have developed advanced ultrasound techniques that could give detailed information about the liver without a biopsy. Unlike a biopsy, these new ultrasound methods are completely non-invasive – meaning no needles or surgery – and would be much safer and more comfortable for patients. The goal is to see if these special ultrasound scans can accurately measure how much fat, inflammation, and scarring is in the liver, helping doctors to diagnose and understand NASH better and earlier.

Key takeaways

This study evaluates new, safer ultrasound techniques to diagnose liver disease.
It aims to reduce the need for invasive liver biopsies for conditions like NASH.
The scans measure liver fat, inflammation, and scarring without needles.
Participation involves special non-invasive scans like advanced ultrasound and MRI.
You can choose to join if you have NAFLD/NASH or as a healthy volunteer (if suitable).

Who may be eligible?

To join this study, you need to be at least 18 years old and understand English or French well enough to give your permission to take part. Researchers are looking for two main groups of people: those who already suspect they have or know they have fatty liver disease (NAFLD or NASH), and also healthy volunteers who don't have liver disease.

If you have or might have NAFLD/NASH, you'll need to be having a liver biopsy for your usual medical care, as this study will compare the new scans to the biopsy results. If you're a healthy volunteer, you shouldn't have any known liver problems or risk factors for fatty liver disease, like certain health conditions or a high body mass index.

You won't be able to join if you are pregnant or trying to get pregnant, or if you can't fit into an MRI scanner. Also, if you have other types of long-term liver conditions, have had a liver transplant, or can't understand what the study involves, you won't be able 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 at least 18 years old?
Do you understand English or French?
Are you NOT pregnant or trying to get pregnant?
If you have NAFLD/NASH, are you due for a liver biopsy as part of your care?
If you are a healthy volunteer, do you have no known liver problems or risk factors?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have several painless scans. These will include special ultrasound tests using something called Acoustic Radiation Force Impulse (ARFI) and also something similar to an MRI scan, called Magnetic Resonance Elastography (MRE). These scans are done as part of the research and will happen around the same time as your liver biopsy, if you are having one for your medical care. The study doesn't involve taking any medication. The total number of visits and the full duration of your participation would be explained to you in detail by the study team, but generally it would involve a single visit for the scans, perhaps over a few hours.

Potential risks and benefits

Taking part in this study could offer several benefits. You would be helping researchers find a safer, non-invasive way to diagnose and monitor serious liver conditions, potentially ending the need for painful biopsies in the future. While there are no new medical treatments involved, you might gain a better understanding of your liver health through the scans. The risks are very low, as the ultrasound and MRI scans are considered very safe, but there's a small chance of discomfort from lying still. Remember, you can choose to leave the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Centre Hospitalier de l'Université de Montréal
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is NAFLD and NASH?

NAFLD is when too much fat builds up in your liver. NASH is a more serious type of NAFLD where there's also inflammation and liver cell damage.

Why are these new scans important?

These new ultrasound scans could potentially replace liver biopsies, which are invasive, making diagnosis much safer and more comfortable for patients.

Will I get medication in this study?

No, this study is only about testing new scanning techniques; no medications are given.

Is the liver biopsy still needed?

For this study, if you have NAFLD/NASH, you'll have a liver biopsy as part of your usual care. The new scans are compared to these results to check their accuracy.

Who is doing this research?

This research is being carried out by medical professionals who have developed these advanced ultrasound techniques. More details would be provided by the study team.

How to find out more

An Tang, MD, MSc

an.tang@umontreal.ca 514-890-8000 Official trial record

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