RecruitingOBSERVATIONAL

Non-Invasive Characterization of Focal Liver Lesions in Liver Cirrhosis

This study is investigating different ways to examine unusual spots (lesions) in the liver of people who have liver scarring, called cirrhosis. The main goal is to use non-invasive methods, which means procedures that don't involve instruments entering the body, to characterise these spots. Researchers want to see how accurate these new imaging techniques are compared to existing standard tests like CT scans, MRI, or tissue samples (biopsies). They also want to find out if these non-invasive methods can help predict how someone's condition might progress or how they will respond to treatment. This research aims to improve how we detect and understand liver issues in people with cirrhosis.

At a glance

Status

Recruiting

Sponsor

University Hospital, Bonn

Enrolment target

200

Start

01 Jan 2016

Estimated completion

31 Dec 2027

Liver Cirrhoses

What is this study about?

If you have liver cirrhosis, a condition where your liver has developed scarring, you might sometimes develop unusual spots, called focal liver lesions. Doctors need to understand what these spots are and how serious they might be. Usually, this involves tests like CT scans or MRI, or sometimes even taking a small tissue sample.

This study is trying to find new, less invasive ways to get information about these liver spots. 'Non-invasive' means that the tests don't involve putting anything inside your body, such as needles or surgical tools. The researchers are particularly interested in using detailed ultrasound scans and looking at muscle changes (called sarcopenia parameters) to characterise these liver spots.

The main aim is to see how accurate these new ultrasound methods are at identifying the nature of the spots compared to the tests doctors currently consider the 'gold standard' – like CT, MRI, or a tissue biopsy. The study also wants to find out if these non-invasive tests can help predict important things like how long someone might live or how well they might respond to treatments. All participants will receive their usual care, and the study will simply add these new investigative tests alongside it.

Key takeaways

New ways to image liver spots are being tested.
Aims to be less invasive than current methods.
Focuses on people with liver scarring (cirrhosis).
May help predict how liver spots behave over time.
Your standard medical care remains unchanged.
Participation involves extra ultrasound scans and measurements.

Who may be eligible?

To be able to take part in this study, you must be an adult aged 18 years or older and already have been diagnosed with liver cirrhosis, as well as having unusual spots or 'lesions' in your liver.

If you are under 18 years old or if you decide you don't want to take part after discussing it with the study team, then you would not be able to join this particular research. The study needs participants who are happy to give their consent, meaning they agree to be involved after understanding what it entails.

Apart from these criteria, the study is open to both men and women across a wide age range, with the focus solely on adults who have the specific liver conditions mentioned.

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?
Have you been diagnosed with liver cirrhosis?
Do you have unusual spots or 'lesions' in your liver?
Are you able to provide your consent to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue to receive all your usual medical care and treatments as normal. The study will simply add some extra assessments on top of your standard care. At the time your liver spots are diagnosed, you would have special detailed ultrasound imaging. This ultrasound is called 'multiparametric ultrasound imaging' and it will look closely at the spots in your liver. They will also look at certain muscle measurements, known as 'sarcopenia parameters'. There are no new medications or procedures involved beyond your standard care; you would just have these specific imaging tests done.

Potential risks and benefits

A potential benefit of joining this study is that you would receive additional, detailed ultrasound imaging of your liver spots, which could provide more information about your condition without needing more invasive tests. There are no significant new risks associated with this study as it involves common, non-invasive imaging (ultrasound) and does not change your existing treatment plan. Your standard care will continue as usual. You have the right to withdraw from the study at any time without giving a reason, and this would not affect your medical care.

Locations (1)

University Hospital Bonn
Verified postcode
Bonn, Germany· Recruiting

Common questions

What are 'focal liver lesions'?

These are simply unusual spots or areas found in your liver that doctors want to investigate further. They can be harmless or sometimes need treatment.

What does 'non-invasive' mean for these tests?

It means the tests don't involve any needles, cuts, or instruments going inside your body. It's usually things like scans or external examinations.

Will my treatment change if I join this study?

No, your treatment and follow-up will remain exactly what your doctors recommend as standard care. This study just adds extra information gathering.

How long will I be in the study?

The study collects information during your normal diagnosis, treatment, and follow-up, so it runs alongside your ongoing medical care. There isn't a fixed end date for individuals.

Do I have to take part?

No, taking part is completely voluntary. Your decision will not affect your medical care in any way.

How to find out more

Michael Praktiknjo, MD

michael.praktiknjo@ukbonn.de +4922828715770 Official trial record

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