NCT04373564 · Guerbet
Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
(ODYSSEY)
What this study is about
This study is a postmarketing requirement jointly carried out by four NDA holders (Bayer AG, Bracco, GE Healthcare and Guerbet) and the CRO IQVIA.
View original scientific description
This study is a postmarketing requirement jointly carried out by four NDA holders (Bayer AG, Bracco, GE Healthcare and Guerbet) and the CRO IQVIA. The study aims to create detailed images of the organs and tissue of the human body during x-ray, CT-scan or MRI investigations, doctors are using contrast media (a kind of dye) which can be given to patients by injection into a blood vessel or by mouth.
Interventions
PROCEDURE
Motor Tests
To assess motor function annually
PROCEDURE
Cognitive Tests
To assess cognitive function annually
PROCEDURE
Unenhanced-MRI of the brain
The UE-MRI of the brain will be performed at baseline and at the year 5 visit in order to exclude presence of a significant MRI abnormality
PROCEDURE
Gadolinium Measurements
Blood samples and spontaneous urine specimens will be collected through the course of the study to measure Gd concentration
DRUG
Gadoxetate disodium
Administered as defined by the treating physician as part of routine clinical practice
DRUG
Gadobenate dimeglumine
Administered as defined by the treating physician as part of routine clinical practice
DRUG
Gadodiamide
Administered as defined by the treating physician as part of routine clinical practice
DRUG
Gadoterate meglumine
Administered as defined by the treating physician as part of routine clinical practice
DRUG
Gadobutrol
Administered as defined by the treating physician as part of routine clinical practice
DRUG
Gadoteridol
Administered as defined by the treating physician as part of routine clinical practice
Primary outcome measures
Change of motor function from baseline to year 5 in comparison to a matched non-GBCA-exposed control group
Time frame: At baseline, year 5
The endpoint is a composite z score, defined as the weighted sum of the z scores of the individual tests
Change in cognitive function from baseline to year 5 in comparison to a matched non-GBCA-exposed control group
Time frame: At baseline, year 5
The endpoint is a composite z score, defined as the weighted sum of the z scores of the individual tests
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participant must be neurologically normal, defined as free of unstable neurologic and psychiatric disease as confirmed by a normal neurologic examination at screening
- Participant (GBCA-exposed or controls) agrees to undergo unenhanced magnetic resonance imaging (UE-MRI) of the brain at enrollment and at the end of the observation period (5 years)
- Participants should have at least 1 of the following indications: a) Medium to high risk for breast cancer or dense breasts undergoing breast cancer screening with MRI, b) Elevated prostate-specific antigen (PSA) and under active diagnostic surveillance for prostate cancer, c) Chronic liver disease (eg, liver cirrhosis limited to Child class A, post-hepatitis chronic hepatopathy, or primary sclerosing cholangitis) for surveillance of hepatocellular carcinoma development, d) Low-grade colorectal cancer or neuroendocrine tumor undergoing screening for liver metastases or e) Branch-duct intraductal papillary mucinous ne
Where
- Scottsdale, Arizona
- New Haven, Connecticut
- Chicago, Illinois
- Peoria, Illinois
- Boston, Massachusetts
- Methuen, Massachusetts
- Worcester, Massachusetts
- St Louis, Missouri
- Chapel Hill, North Carolina
- Hershey, Pennsylvania
- Philadelphia, Pennsylvania
- Dallas, Texas
And 2 more locations — see the full list below.
Collaborators
Bayer AG (Sponsor), Bracco (Sponsor), GEHC (Sponsor)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 22, 2026 · Source of record for eligibility and locations