RecruitingPHASE4INTERVENTIONAL

Phase 4 Paediatric Study to Evaluate Sonazoid Safety and Efficacy for Contrast-Enhanced Ultrasound Liver Imaging

This study is for children under 18 who have been found to have a growth in their liver. Doctors want to see if using a special ultrasound scan, called a Contrast-Enhanced Ultrasound (CEUS), with a dye named Sonazoid, can help them better understand these growths. Often, liver growths in children are harmless, but some can be more serious. This study will compare the results of the special ultrasound with other tests to find out if it's an accurate and safe way to check these growths. The goal is to help doctors spot problems earlier and make better decisions about a child's care, ultimately improving their chances of a good outcome.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

GE Healthcare

Enrolment target

Start

20 Jan 2025

Estimated completion

31 Oct 2026

Focal Liver Lesions

What is this study about?

Every year, some children are found to have growths in their liver. While many of these are harmless, some can be more serious. Because these growths often don't cause clear symptoms early on, doctors need good ways to find them and understand what kind they are as soon as possible. Getting an accurate diagnosis early on is really important for planning the best treatment and improving a child's health.

Regular ultrasound scans are often the first test doctors use for children because they are safe, easy, and don't hurt. They can be done with parents in the room, which helps everyone feel more comfortable. This study is looking at a more advanced type of ultrasound called Contrast-Enhanced Ultrasound (CEUS), which uses a special dye called Sonazoid. This dye helps doctors see the blood flow within the liver growth much more clearly.

The main aim of this study is to see how accurate and safe this special CEUS scan with Sonazoid is for children. Doctors will compare the results from the CEUS scan with other tests, including biopsies (taking a small sample of the growth) or other advanced scans like MRI or CT. By doing this, they hope to learn if CEUS with Sonazoid can be a valuable tool to help them quickly and safely understand liver growths in children, helping them make the best decisions for each child's health.

Key takeaways

The study evaluates a special ultrasound using Sonazoid dye for liver growths in children.
It aims to improve how doctors tell if liver growths are harmless or serious.
Participation involves a Contrast-Enhanced Ultrasound (CEUS) after receiving the dye.
The dye helps doctors see blood flow in the growth more clearly.
The study compares CEUS results with other tests to check its accuracy and safety.
Early and accurate diagnosis helps doctors plan the best treatment.

Who may be eligible?

This study is looking for children under 18 years old who have at least one liver growth that hasn't been treated yet. The growth should be a certain size and be visible on a regular ultrasound. They also need to have had, or be scheduled to have, another type of advanced liver scan (like a special MRI or CT scan) around the time they join the study.

Before joining, a parent or legal guardian will need to understand the study and give permission. If your child is old enough to understand, they will also be asked to agree to take part. There are a few other checks, like for any allergies to the study drug (Sonazoid) or if girls who have started their periods might be pregnant.

Children cannot join if they have a known allergy to Sonazoid or eggs, or if they have a very serious illness that doctors expect to be life-threatening within six months. Also, if your child has previously had Sonazoid, they won't be eligible for this study.

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.

Is your child under 18 years old?
Does your child have a liver growth that hasn't been treated yet?
Has your child had (or will they have soon) another advanced liver scan like an MRI or CT?
Will a parent or guardian be able to give permission and ensure your child follows study procedures?
Does your child have any known allergies to eggs or Sonazoid?
Is your child's body weight 3kg or more?

Answer every question to see your result.

What does participation involve?

If your child joins this study, they will have a special ultrasound scan called a Contrast-Enhanced Ultrasound (CEUS). This involves first having a regular ultrasound of their liver growth. Then, a small amount of the Sonazoid dye will be given into a vein, and the ultrasound will be repeated to see how the dye highlights the blood flow in the growth. All of this will happen during one visit.

Throughout the study, doctors will collect information about your child's health and any side effects. The results of the scans will be looked at by three different expert doctors who won't know your child's other medical information, to ensure the readings are fair and accurate. The study will last for as long as it takes to complete the examinations and collect the safety information.

Potential risks and benefits

Taking part in this study may offer a potential benefit by providing doctors with more detailed information about your child's liver growth using a new imaging technique. This information might help guide future treatment decisions. However, it's important to remember that this is a research study, and we can't guarantee a direct benefit to your child. Potential risks include discomfort from the injection of the Sonazoid dye, and there's a very small chance of allergic reaction to the dye. All effects will be carefully monitored by the study team. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their ongoing medical care.

Locations (6)

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

Munich University Hospital
Verified postcode
München, Germany· Not yet recruiting
Papa Giovanni XXIII Hospital
Verified postcode
Bergamo, Italy· Not yet recruiting
Giannina Gaslini Institute
Verified postcode
Genoa, Italy· Not yet recruiting
University Hospitals Bristol and Weston NHS Foundation Trust
Verified postcode
Bristol, United Kingdom· Recruiting
King's College Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Sonazoid?

Sonazoid is a special liquid containing tiny bubbles that helps doctors see blood flow more clearly on an ultrasound scan, especially in areas like liver growths.

Will my child feel anything during the scan?

Your child might feel a small prick when the Sonazoid dye is given into a vein, similar to a blood test. The ultrasound itself is generally painless.

How long will the visit take?

The visit for the ultrasound scans and receiving the Sonazoid dye will likely take a few hours, including preparation and monitoring afterwards.

Is the Sonazoid dye safe?

Yes, Sonazoid has been used in medical imaging. The study team will carefully monitor your child for any side effects, and the dose is adjusted for children based on their weight.

What happens after the study?

After the study, your child will continue to receive their standard medical care. The information gathered from this study will help improve diagnosis for other children in the future.

How to find out more

Tingting Wang

tingting.wang12@gehealthcare.com +86 21 3895 4500 Official trial record

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