(21196) A multicenter, prospective, open-label study to evaluate the pharmacokinetics and safety of gadoquatrane in pediatric participants (from birth to <18 years) undergoing contrast-enhanced magnetic resonance imaging (CE-MRI)
This study is testing a new contrast dye, called gadoquatrane, for MRI scans in children. Doctors use contrast dyes to make parts of the body show up more clearly on an MRI, which helps them see problems better. We want to learn how a child's body processes this new dye – for example, how much of it stays in the blood and for how long. We also want to check carefully for any side effects to make sure it's safe. This information is important for making sure children needing MRI scans get the safest and most effective imaging possible. The study includes children from babies right up to teenagers under 18 years old.
At a glance
What is this study about?
Imagine you're taking a normal photo, but some parts are a bit blurry or hard to see. Now imagine you could add a special filter that makes those important parts really stand out. That's a bit like what a contrast dye does for an MRI scan. An MRI (Magnetic Resonance Imaging) uses strong magnets and radio waves to create detailed pictures inside your body. Sometimes, doctors need even clearer pictures, especially when looking for things like infections, tumours, or other problems in organs and tissues. That's where a contrast dye comes in.
This study is focusing on a new contrast dye called gadoquatrane. It's known as a 'Phase III' study, which means it’s one of the final steps in testing a new medicine or treatment before it can be used more widely. Researchers want to understand two key things about gadoquatrane in children: firstly, how a child's body handles the dye (this is called 'pharmacokinetics'). This involves looking at how much of the dye stays in the blood, how quickly the body gets rid of it, and how it spreads through the body – all important details for giving the right dose. Secondly, and just as importantly, they want to make sure it's safe and doesn't cause too many side effects.
By carefully studying gadoquatrane in children of different ages, from newborns up to teenagers, doctors hope to gather enough information to confirm that it's a safe and effective option for contrast-enhanced MRI scans in young patients. This research is vital because children's bodies react differently to medicines than adults', so it's important to test new treatments specifically in this age group.
Key takeaways
- This study tests a new contrast dye called gadoquatrane for MRI scans in children.
- It aims to understand how a child's body processes the dye and to check its safety.
- Children from birth up to 17 years old can take part.
- Participation involves receiving the dye, blood tests, an MRI, and follow-up checks for 7 days.
- The study helps develop safer and more effective imaging for young patients.
Who may be eligible?
This study is looking for children of all ages, from newborns (babies from birth) right up to teenagers under 18 years old. Both boys and girls can take part. The most important thing is that the child needs to have a contrast-enhanced MRI scan as part of their medical care, and their doctors think this study might be suitable for them.
There will be specific health checks and medical history reviews to make sure each child is right for the study. For example, children with certain medical conditions or those taking particular medications might not be able to participate, as these could affect how the body handles the study drug or make it unsafe. The study team will go through all of these details with you.
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 my child under 18 years old?
- Does my child need a contrast-enhanced MRI scan?
- Does my child have any serious health conditions?
- Is my child currently taking any regular medication?
- Am I comfortable with my child having blood tests?
What does participation involve?
If your child takes part in this study, they will receive the new contrast dye, gadoquatrane, as a single injection before their MRI scan, just like they would with other contrast dyes. The study team will take several blood samples at different times after the injection to see how the dye moves through and leaves the body. Your child will be carefully monitored for any side effects during this time.
After the injection, your child will have their contrast-enhanced MRI scan as planned. The medical team will continue to check on your child's well-being for a total of 7 days following the injection to record any changes or side effects. There might be a follow-up phone call or visit during this period. The total duration of active participation, including follow-up, will be around a week after the injection.
Potential risks and benefits
Locations (7)
- —UnverifiedPoland
- —UnverifiedSweden
- —UnverifiedCzechia
- —UnverifiedHungary
- —UnverifiedBulgaria
- —UnverifiedGermany
- —UnverifiedItaly
Common questions
What is a contrast dye?
It's a special liquid given before an MRI scan to help doctors see certain parts of the body more clearly, like highlighting them.
Why is this study important for children?
Children's bodies handle medicines differently than adults, so it's crucial to test new dyes specifically in kids to make sure they are safe and work well for them.
Will my child still get their MRI scan?
Yes, your child will still have their planned contrast-enhanced MRI scan as part of their medical treatment.
What will happen after the injection?
Your child will be carefully watched for about 7 days to check for any side effects, and some blood samples will be taken to see how the dye works in the body.
Can we change our minds about taking part?
Yes, you can decide to leave the study at any point, and it won't affect your child's medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.