(21197) 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 any body region (except CNS), compared to 0.1 mmol Gd/kg approved macrocyclic gadolinium-based contrast agents (GBCAs)
This study looks at a new MRI dye called gadoquatrane. MRI scans often use a special dye to make certain body parts or problems show up more clearly. This research aims to compare gadoquatrane with the dyes currently used, like gadoteric acid, to see if it works better or the same way. Researchers want to find out if the new dye helps doctors see things like growths or changes in organs more clearly in MRI scans of the body (but not the brain or spinal cord). They are also checking to make sure the new dye is safe for patients. The study involves adults aged 18 and over.
At a glance
What is this study about?
Imagine you're having an MRI scan. Sometimes, doctors use a special liquid, called a contrast agent or dye, to make parts of your body or any problems show up more clearly on the scan. It's a bit like adding colour to a drawing so you can see the details better.
This study is testing a brand-new MRI dye called gadoquatrane. Researchers want to compare it with the dyes doctors currently use to see if it's just as good, or even better, at helping them see things inside your body. They're particularly interested in whether gadoquatrane helps doctors identify and see problems in organs or other body parts more clearly, but specifically not in the brain or spinal cord. They are also carefully watching to make sure the new dye is safe to use.
The main goal is to find out if gadoquatrane helps doctors get clearer pictures, see the edges of any problems better, and understand what they are looking at in the MRI. They will also check how helpful the scans are for making diagnoses and deciding on the best care for patients.
Key takeaways
- New MRI dye (gadoquatrane) is being tested.
- Comparing gadoquatrane to standard MRI dyes.
- Aims to see if it helps doctors get clearer body scans (not brain/spine).
- Also checking for safety of the new dye.
- Involves adults aged 18 and over.
- You would receive both dyes for different scans.
Who may be eligible?
This study is open to adults aged 18 and older. Both men and women can take part.
You might be considered for this study if your doctor thinks you have a medical condition or problem in your body that isn't in your brain or spinal cord, and you're scheduled to have an MRI scan with a special dye.
There will be specific reasons why someone might not be able to join, such as certain health conditions or medications, to ensure the study is safe for everyone involved. Your doctor will be able to discuss these with you in more detail.
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?
- Do you need an MRI scan that uses a special dye?
- Is the MRI scan for a part of your body other than your brain or spinal cord?
- Do you have a known or suspected medical condition that needs checking with an MRI?
What does participation involve?
If you decide to take part, you would receive the new dye (gadoquatrane) for one MRI scan and one of the standard, approved dyes for another MRI scan. These scans will happen at different times, often very close together, in a 'cross-over' way. This helps researchers compare the dyes in the same person. During your visits, you will have standard MRI procedures, which include lying still in the scanner. You will also have blood tests and physical check-ups to monitor your health and any side effects. The total duration of your participation, including all scans and follow-up, will be explained by the study team.
Potential risks and benefits
Locations (8)
- —UnverifiedCzechia
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- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedBulgaria
- —UnverifiedPoland
- —UnverifiedGermany
- —UnverifiedHungary
Common questions
What is an MRI dye?
It's a special liquid given before an MRI scan to make certain parts of your body or any problems show up more clearly on the pictures.
Why is this study important?
It helps us find out if a new MRI dye works better or is safer than the ones we use now, potentially improving how doctors diagnose conditions.
Will this study look at my brain or spinal cord?
No, this study specifically focuses on MRI scans of other parts of the body, not the brain or spinal cord.
Will I get a new dye and a standard dye?
Yes, you would receive both the new dye and a standard approved dye for different scans, allowing for a direct comparison.
Can I leave the study at any time?
Yes, you are free to stop participating in the study at any point, and your medical care will not be affected.
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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