(21181) A multicenter, randomized, prospective double-blind, cross over Phase 3 study to evaluate the efficacy and safety of 0.04 mmol Gd/kg body weight of gadoquatrane for MRI in adults with known or suspected pathology of the central nervous system (CNS), compared to 0.1 mmol Gd/kg approved macrocyclic gadolinium-based contrast agents (GBCAs)
This important study is looking into a new contrast dye, gadoquatrane, used during MRI scans of the brain and spinal cord. When you have an MRI, a special dye is often injected to help doctors see certain areas more clearly. This trial aims to find out if gadoquatrane, used at a lower dose, works just as well and is as safe as the current dyes available. The goal is to see if it makes problems like tumours or inflammation easy to spot and helps doctors make accurate diagnoses. The study compares gadoquatrane to existing dyes to ensure we continue to provide the best and safest care for people needing these scans.
At a glance
What is this study about?
Imagine you're having an MRI scan of your brain or spinal cord because your doctor needs a really clear picture to understand what's going on. Sometimes, they use a special 'contrast dye' that's injected into your vein. This dye acts like a highlighter, making certain areas or problems, such as a growth or inflammation, show up much more clearly on the scan. This helps doctors see things they might otherwise miss and make a more accurate diagnosis.
This particular study is like a test run for a new contrast dye called gadoquatrane. We want to see if it works as well as the dyes currently used, but at a potentially lower dose. Finding a dye that works effectively at a lower dose could be beneficial, as it means less of the substance is put into your body.
During the study, doctors will compare how well gadoquatrane helps them see various conditions in the brain and spinal cord, such as tumours or other changes. They'll look at how clearly problems are outlined and how easy they are to identify, making sure any new dye is just as good, or even better, than what we have now. This research is a crucial step in making sure MRI scans remain as safe and effective as possible for patients.
Key takeaways
- Testing a new contrast dye called gadoquatrane for MRI scans.
- Aims to see if the new dye works well at a lower dose.
- Compares gadoquatrane to standard contrast dyes.
- Focuses on MRI scans of the brain and spinal cord.
- Participation involves MRI scans and check-ups, with unknown dye type.
Who may be eligible?
This study is looking for adult volunteers, aged 18 years or older. Both men and women can take part.
You would be considered if you are scheduled for an MRI scan of your brain or spinal cord because your doctor suspects you might have a particular condition, or if you already know you have a condition there that needs checking. This means you’re already due for a scan where a contrast dye would normally be used.
There might be some specific health conditions that would prevent you from joining, or certain medications you're taking. The study doctor would review your full medical history to confirm if this study is suitable for 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.
- Are you 18 years old or older?
- Are you scheduled for an MRI of your brain or spinal cord?
- Does your doctor suspect a condition in your brain or spinal cord, or do you have a known condition there?
- Are you able to attend multiple study visits for scans and check-ups?
What does participation involve?
If you join this study, you won't know which contrast dye you receive – it could be the new gadoquatrane or one of the standard dyes already in use. You'll have MRI scans both before and after receiving the dye. Expert doctors, who also won't know which dye you had, will carefully look at these scans to compare how well they show different parts of your brain or spinal cord.
This study is designed as a 'crossover' study, meaning that at some point, you might receive both the new dye and a standard dye, but at different times. This helps researchers directly compare them. You'll likely have a few appointments for scans and check-ups. The total time you'd be involved in the study would depend on the specific schedule, but it would involve multiple visits over a period that the study team will explain fully. There won't be any new medication for you to take; it's about the dye used during your MRI.
Potential risks and benefits
Locations (7)
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- —UnverifiedHungary
- —UnverifiedCzechia
- —UnverifiedGermany
Common questions
What is a contrast dye?
It's a special liquid injected during an MRI to help make parts of your body, like blood vessels or specific tissues, show up more clearly on the scan.
Why is a 'lower dose' important?
Using a lower dose means less of the substance is put into your body, which could potentially be safer while still giving clear scan results.
Will I know which dye I received?
No, this is a 'blinded' study, meaning neither you nor your doctor will know which specific dye you received until after the study is complete, allowing for unbiased results.
What parts of my body are being scanned?
This study focuses on MRI scans of your brain and spinal cord, also known as the central nervous system.
Who is running this study?
This is a large, multipatient-friendly-site study, meaning several hospitals or clinics are taking part in the research.
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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