AuthorisedTherapeutic use (Phase IV)Interventional

Prospective evaluation of potential effects of repeated gadolinium-based contrast agent (GBCA) administrations of the same GBCA on motor and cognitive functions in neurologically normal adults in comparison to a non-GBCA exposed control group—ODYSSEY

The ODYSSEY study is looking into whether having several MRI scans with special dyes, called gadolinium-based contrast agents (GBCAs), can affect a person's ability to move or think over a long period. Researchers will follow neurologically healthy adults for five years. Some participants will have received specific types of GBCA dyes for their MRIs, while others, forming a comparison group, will not have had these dyes. The study will carefully measure any changes in movement and thinking skills in all participants from the start of the study to the end of the five years. This will help doctors understand more about the long-term effects of these commonly used scan dyes.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Iqvia Rds France

Enrolment target

717

Start

27 Nov 2024

What is this study about?

Imagine you're going for an MRI scan, and sometimes doctors use a special dye to make things show up more clearly. These dyes are called 'gadolinium-based contrast agents' (GBCAs). This study, called ODYSSEY, is looking into whether having these dyes several times for different scans might have any long-term effects on how well you move your body (like walking or picking things up) or how well your brain thinks (like remembering things or focusing).

Researchers will follow neurologically healthy adults for five years. They will compare people who have had these dyes for their MRIs to a similar group of people who haven't had them. The main goal is to see if there's any difference in their movement and thinking skills after five years. This is a "Phase IV" study, which means the dyes are already approved and in use, and this research is about understanding their effects over a longer time in real-world situations.

It's really important to understand any possible long-term effects of treatments that doctors use every day. By carefully measuring changes in movement and thinking, and also checking for any unexpected health problems, the ODYSSEY study aims to give us a clearer picture of how these MRI dyes might affect people over time. This information will help doctors make better decisions about using these dyes and reassure patients about their safety.

Key takeaways

The study looks at long-term effects of MRI dyes (GBCAs).
It checks if these dyes affect movement or thinking over five years.
Compares those who receive dyes to those who don't.
Participants will have yearly check-ups, including movement and thinking tests.
Aims to improve understanding of MRI dye safety for future patients.

Who may be eligible?

To be part of this study, you need to be an adult, at least 18 years old. Both men and women can take part.

This study is for people who are generally healthy in terms of their brain and nervous system – meaning you don't have known neurological conditions. The study is specifically looking at how the body reacts to certain MRI dyes over time, so they want to ensure participants are otherwise well.

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 generally healthy, with no known brain or nerve conditions?
Are you able to attend yearly appointments for five years?
Are you willing to provide blood and urine samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the ODYSSEY study, you would be followed for a full five years. Each year, you would have a visit where researchers would check your movement and thinking skills through various tests. These tests are designed to see if there are any subtle changes over time. They will also look for any new health problems you might experience.

During these annual visits, blood and urine samples will be collected. If you happen to have a routine MRI scan with a contrast dye around the time of your visit, the samples would be collected before that scan. The study is not giving you any new medication or contrast dye; it's observing people who have received or will receive certain MRI contrast dyes as part of their regular medical care. The total duration of your involvement, including all visits and tests, would be five years.

Potential risks and benefits

Taking part in this study could help doctors understand more about the long-term effects of common MRI dyes, which could benefit many patients in the future. There are no direct medical treatments or interventions given in this study. The main risks involve the time commitment for annual visits and the minor discomfort of blood and urine collection. As with any study, you are completely free to withdraw at any time without giving a reason, and it will not affect your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Germany
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Unverified
France

Common questions

What are gadolinium-based contrast agents (GBCAs)?

GBCAs are special dyes used in MRI scans to make certain body parts or problems show up more clearly on the images.

What does 'neurologically normal adults' mean?

It means adults who do not have any known conditions affecting their brain or nervous system.

Will I get any new medicine or treatment in this study?

No, this study is about observing the long-term effects of MRI dyes you might receive as part of your usual medical care, not giving new treatments.

How long will I be in the study?

If you join, you will be part of the study for five years, with annual check-ups.

What kinds of tests will I have?

You will have tests to check your movement abilities and how well your brain thinks, along with blood and urine tests.