A Prospective, Multi-National, Randomized, Double-Blind, Crossover Study to Evaluate the Efficacy and Safety of Gadopiclenol-enhanced MRA Compared to Gadoterate Meglumine-enhanced MRA in the Assessment of Steno-occlusive Disease in Adult Patients with Suspected Vascular Disease
This research study is looking at two different types of special dyes, called Gadopiclenol and Gadoterate Meglumine (also known as Dotarem), that are used during MRI scans to create clearer pictures of your blood vessels. The study is for adults who are suspected of having narrowed or blocked blood vessels, for example, in their neck, legs, or around their kidneys. Both you and your doctors won't know which dye you're receiving at the time. The main goal is to find out which dye is better at helping doctors accurately diagnose these blood vessel problems and which one is safer. This is a late-stage study, meaning it's building on earlier research to confirm the best approach.
At a glance
What is this study about?
This study is designed to help doctors get the best possible pictures of your blood vessels using a special type of scan called an MRI (Magnetic Resonance Imaging). Sometimes, to make the blood vessels stand out more clearly on these scans, a special dye is given through an injection. This study is comparing two different dyes: Gadopiclenol and an existing dye called Gadoterate Meglumine (or Dotarem).
The main aim is to see which of these dyes helps doctors more accurately identify if there are any narrowings or blockages in your blood vessels, and to make sure they are safe to use. This kind of problem is sometimes called 'steno-occlusive disease' and can affect blood vessels in various parts of your body, such as those that go to your brain, legs, or kidneys. By getting clearer pictures, doctors can make more informed decisions about your care.
This is a 'Phase III' study, which means it's a very important step before a new medicine or dye can be widely used. It builds on previous research, and its purpose is to confirm the effectiveness and safety of Gadopiclenol compared to a dye that is already in use. The results will help medical professionals choose the best methods for diagnosing blood vessel conditions in the future.
Key takeaways
- This study compares two MRI dyes for spotting blood vessel problems.
- It's for adults with suspected narrowed or blocked blood vessels.
- You'll receive both dyes during different MRI scans, without knowing which one.
- The aim is to find the best and safest dye for clear diagnosis.
- Your participation could help improve future medical imaging for others.
Who may be eligible?
This study is open to adult men and women, aged 18 years old and above. There isn't an upper age limit, so older adults can also take part if they meet other health requirements.
To be considered for this study, doctors must suspect that you might have blood vessel problems. This could involve conditions affecting the arteries leading to your brain, in your arms or legs, or those supplying your belly or kidneys. The goal is to investigate these potential issues using the MRI scans.
There will be specific health checks and assessments to ensure that it's safe for you to take part and that the study results will be clear and useful. Your doctor will discuss all the detailed criteria with you to see if this study is a good fit.
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 your doctors suspect you might have a problem with your blood vessels (e.g., in your neck, legs, or near your kidneys)?
- Are you able to have an MRI scan?
- Are you able to attend several clinic appointments?
What does participation involve?
If you decide to take part in this study, you will have at least two MRI scans of your blood vessels. Before each scan, you will receive an injection of one of the study dyes. You will be randomly assigned to receive Gadopiclenol for one scan and Gadoterate Meglumine for the other, but neither you nor your study doctor will know which dye you're getting at the time of each scan (this is called 'double-blind').
There will be some visits to the clinic for assessments before and after your scans. These visits may include blood tests, a review of your medical history, and discussions about any symptoms you might have. You'll also be asked about any side effects you experience.
The study involves a 'crossover' design, meaning you will receive both dyes at different times. After receiving the first dye and having an MRI, there will be a waiting period before you receive the second dye and have another MRI scan. The total duration of your participation in the study will depend on the schedule agreed upon with your study team, and they will fully explain all appointments and follow-up activities.
Potential risks and benefits
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Common questions
What is an MRI scan?
An MRI scan uses strong magnets and radio waves to create detailed pictures of organs and structures inside your body, without using X-rays.
Why do I need a special dye for the MRI?
The dye helps make your blood vessels show up more clearly on the MRI pictures, making it easier for doctors to spot any problems like narrowings or blockages.
Will I know which dye I'm getting?
No, neither you nor your study doctor will know which dye you receive during each scan. This helps ensure the study results are fair and unbiased.
What kind of blood vessel problems is this study looking at?
The study is looking for narrowings or blockages in arteries that supply blood to your brain, legs, or organs in your belly, like the kidneys.
Is the new dye safe?
The new dye, Gadopiclenol, has been tested in earlier studies. This study is a final stage to confirm its safety and effectiveness on a larger scale.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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