A Phase 4, Open-Label, Non-randomised, Multicentre Study to Evaluate Safety and Efficacy of Intravenous Administration of Sonazoid™ for Contrast-Enhanced Ultrasound Liver Imaging in Paediatric Patients.
This study is for children who have spots on their liver. It's looking at a special type of ultrasound scan that uses a substance called Sonazoid™. This substance helps doctors get a clearer picture of these liver spots, often called focal liver lesions (FLLs). The main goal is to check how accurately the Sonazoid™-enhanced scan can help tell if a spot is harmless (benign) or whether it might be something more serious (malignant). Doctors will compare these new scan results with information they already have from other tests like CT scans or biopsies. They will also look at safety, recording any side effects that might happen after using Sonazoid™.
At a glance
What is this study about?
Imagine your child has had an ultrasound or other scan, and doctors have noticed a small area on their liver that looks a bit different – they call these 'focal liver lesions' or FLLs. Often, these are completely harmless, but sometimes doctors need to do more tests to be sure. This study is about helping doctors get a clearer picture of these spots using a special type of ultrasound scan.
This special scan uses a substance called Sonazoid™. Think of Sonazoid™ as a temporary 'dye' that's given through a vein. It's made of tiny bubbles that show up very brightly on an ultrasound, helping the doctors see the blood flow within these liver spots much more clearly. By watching how the Sonazoid™ moves in and out of the spot, doctors can learn more about its characteristics. This extra information can help them decide if the spot is likely to be harmless or if it needs further investigation or treatment.
The study aims to find out how accurate this Sonazoid™-enhanced ultrasound is in helping doctors tell the difference between harmless and potentially serious liver spots in children. They will compare the results of these special ultrasounds with information already gathered from other well-known tests children might have had, like sophisticated CT or MRI scans, or even a small tissue sample (biopsy) if that was done. They'll also be closely monitoring any side effects to make sure Sonazoid™ is safe for children.
Key takeaways
- This study uses a special ultrasound with Sonazoid™ to look at liver spots in children.
- It aims to see how well this helps tell if liver spots are harmless or serious.
- Sonazoid™ is given through a vein and helps doctors see blood flow clearly.
- The study compares results with existing diagnosis information (e.g., from CT/MRI).
- Safety of Sonazoid™ in children is also being carefully checked.
- Participation involves one scan and monitoring for about 3 days.
Who may be eligible?
This study is looking for children of any age who have a spot on their liver that doctors want to investigate further. Both boys and girls can take part.
To be eligible, your child would already have been diagnosed with a 'focal liver lesion' (a spot on the liver) by other standard medical imaging tests or, in some cases, by a biopsy.
More detailed checks will be done by the study team to ensure your child meets all the specific requirements and that it's safe for them 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.
- Does my child have a spot on their liver that doctors want to investigate?
- Has their liver spot been diagnosed by another scan (like CT, MRI) or a biopsy?
- Is my child currently under the care of a specialist for their liver condition?
- Am I comfortable with my child receiving a special liquid (Sonazoid™) into a vein?
What does participation involve?
If your child takes part, they would receive a dose of Sonazoid™ through a small tube placed in a vein. This is typically done during an ultrasound scan already scheduled for their liver. The doctors would then perform the special ultrasound scan, watching how the Sonazoid™ highlights the liver spot at different stages, including how blood moves through it and how it behaves over time.
After the scan, your child and you would be monitored for a short period, typically up to 72 hours (3 days), to check for any side effects. The total duration of active participation in the study, including scans and monitoring, would be fairly short, usually within this 72-hour window. There wouldn't be additional special 'visits' just for the study beyond attending their scheduled scan appointments.
Potential risks and benefits
Locations (2)
- —UnverifiedItaly
- —UnverifiedGermany
Common questions
What is Sonazoid™?
Sonazoid™ is a special liquid containing tiny bubbles that helps make ultrasound scans of the liver clearer, especially for spotting areas that might look different.
Is Sonazoid™ similar to a dye for CT or MRI scans?
While it helps 'highlight' areas like dyes in CT/MRI, Sonazoid™ works differently and relies on ultrasound technology. It's not the same type of substance.
What does 'focal liver lesion' mean?
It's just a medical term for a specific spot or area on the liver that looks different on a scan.
Will taking part change my child's current treatment?
This study is about learning more about the diagnosis. Any decisions about your child's treatment would still be made by their doctors based on all available information, including the results of this scan.
How long will my child be involved in the study?
Your child's active involvement, including the scan and monitoring, would typically be completed within 72 hours (3 days) after receiving Sonazoid™.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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