Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
This study, sponsored by several healthcare companies, is investigating the potential effects of a special dye called gadolinium (which doctors use in MRI scans) on people's body movement and mental skills. Some patients need these scans often, so researchers want to see if having this dye multiple times over five years has any impact. They will compare people who regularly receive this dye for their MRIs with a group who do not. The study involves health checks, specific movement and thinking tests, and special MRI scans to see if there are any changes. It's a large study involving over 2000 adults up to 65 years old, lasting five years.
At a glance
What is this study about?
When doctors need a very clear picture of what's happening inside your body, they sometimes use a special dye, often called a 'contrast agent,' during tests like MRI scans. This dye helps certain parts of your body show up more clearly on the images, helping doctors make a better diagnosis. One common type of dye contains a substance called gadolinium.
Because some people need MRI scans regularly over several years for their health conditions, doctors and researchers want to understand if having gadolinium-based dyes many times might affect their body movement (like coordination or balance) or their mental skills (like memory or thinking clearly). This study aims to find out by carefully observing a large group of people over five years.
It's important to know that doctors don't think these dyes are harmful for most people, but this research is about making sure. By comparing people who have received these dyes often with a similar group who haven't, the study will provide valuable information to help doctors and patients make informed choices about medical imaging in the future.
Key takeaways
- This study is about understanding the long-term effects of MRI dyes on movement and thinking.
- It lasts five years and observes people who get regular MRI scans.
- The study includes extra tests of movement, thinking, blood, and urine.
- You must be between 18 and 64 and have a specific health condition to join.
- Results will help doctors make better decisions about MRI dyes for future patients.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you need to be an adult between 18 and 64 years old and generally healthy in terms of your brain and mental health. This means you shouldn't have any serious or unstable neurological (brain or nerve) or psychiatric (mental health) conditions.
You also need to have a specific health condition that requires you to have regular MRI scans. These conditions include certain risks for breast or prostate cancer, some chronic liver diseases, particular types of bowel cancer, or a specific type of pancreatic cyst. If you're in the group that receives the gadolinium dye, you should be expected to have at least five MRI scans with the same gadolinium-based dye over the five years of the study. If you've had a few gadolinium scans before the study, that's usually okay, as long as it was the same type of dye.
For those in the control group (who don't receive the gadolinium dye), you must not have had any gadolinium dye injections in the past and shouldn't be expected to have any during the study. All participants must agree to have special MRI scans of their brain at the start and end of the study, and potentially other scans depending on their medical care.
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 between 18 and 64 years old?
- Do you have good general brain and mental health?
- Do you have a condition requiring regular MRI scans (e.g., for breast cancer risk, prostate cancer, liver disease, certain bowel cancers, or pancreatic cysts)?
- Are you willing to have two extra brain MRI scans (without dye) and regular movement/thinking tests?
- If you're in the dye group: Are you likely to have at least five MRI scans with the same gadolinium dye over five years?
- If you're in the non-dye group: Have you never had a gadolinium injection, and are you not expected to have one during the study?
What does participation involve?
If you join this study, it will last for five years. During this time, you will continue with your regular MRI scans or other imaging tests (like CT scans or X-rays) for your ongoing medical care, as decided by your doctors. You will also visit the study doctor at least seven times over the five years.
At these visits, you'll have physical examinations, blood and urine tests, and specific tests to check your body movement and mental skills. Everyone in the study will also have two special MRI scans of their brain (without any dye) – one at the very beginning and one at the end of the five years. These extra scans, blood tests, and movement/thinking tests are what make this a research study, as they wouldn't normally be part of your routine medical care for your existing condition.
Potential risks and benefits
Locations (51)
- Scottsdale Medical Imaging, LLCVerified postcodeScottsdale, United States· Recruiting
- Yale University School of MedicineVerified postcodeNew Haven, United States· Withdrawn
- University of Chicago Medical CenterVerified postcodeChicago, United States· Recruiting
- Methodist Medical Center of IllinoisVerified postcodePeoria, United States· Recruiting
- Massachussets General HospitalVerified postcodeBoston, United States· Recruiting
- Boston University Medical CenterVerified postcodeBoston, United States· Terminated
- Beth Israel Deaconess Medical CenterVerified postcodeBoston, United States· Withdrawn
- ActivMed Practices & Research, Inc.Verified postcodeMethuen, United States· Withdrawn
- University of Massachusetts Memorial Medical CenterVerified postcodeWorcester, United States· Terminated
- Department of RadiologyVerified postcodeSt Louis, United States· Withdrawn
- UNC School of MedicineVerified postcodeChapel Hill, United States· Withdrawn
- Penn State Hershey Medical CenterVerified postcodeHershey, United States· Recruiting
Common questions
What is gadolinium and why is it used?
Gadolinium is a special substance used as a dye in some MRI scans. It helps make internal organs and tissues show up more clearly, which helps doctors see problems better.
Will I receive a new medicine as part of this study?
No, you won't receive any new medicines. The study is observing people who already receive gadolinium dyes for their routine MRI scans, or those who don't.
What kind of mental skills will be tested?
The study will use specific tasks and puzzles to check different mental skills, like memory, how quickly you process information, and your ability to focus.
How often will I need to visit the clinic?
You'll need to visit the study doctor at least seven times over the five years of the study, in addition to your regular medical appointments.
What if I decide I don't want to continue the study?
You can leave the study at any time, for any reason, without having to explain why. It will not affect your usual medical care.
How to find out more
Nathalie LE FUR, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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