Study on Gadolinium-based Contrast Media and Body/Mental Skills
This study is looking into whether gadolinium-based contrast agents (GBCAs), like Gadoxetate disodium, affect your body movement (motor function) and thinking skills (cognitive function) if you receive them multiple times over five years. Researchers will compare people who receive GBCAs during MRI scans to a similar group who do not. The study will measure changes in your motor and cognitive functions from the beginning to the end of the five-year period. You can join if you are between 18 and 64 years old, have normal brain function, and agree to have special brain MRI scans at the start and end of the study. The current status of this study is unclear.
- Study design
- This interventional study plans to enroll about 2076 participants. It compares people who receive gadolinium-based contrast agents to a matched control group.
- What's involved
- You would undergo motor and cognitive tests annually, and have unenhanced MRI scans of your brain at the beginning and end of the five-year study. Blood and urine samples would also be collected throughout the study to measure gadolinium levels.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your motor and cognitive function will be assessed at baseline and again at year 5.
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NCT04373564
Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
Recruiting
PHASE4Ages 18–64InterventionalGuerbet
~2,076 participants
Updated 2026-01-22 on ClinicalTrials.gov
What's tested:Motor TestsCognitive TestsUnenhanced-MRI of the brainGadolinium MeasurementsGadoxetate disodiumGadobenate dimeglumine
At a glance
Recruiting sites
25 of 51 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change of motor function from baseline to year 5 in comparison to a matched non-GBCA-exposed control group
Measured over At baseline, year 5
+1 more outcome measured
Conditions
Where it's being run
51 sites across 26 statesRussia7
Massachusetts5
South Korea5
São Paulo4
Italy3
Illinois2
Pennsylvania2
Texas2
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 neoplasm (IPMN) of the pancreas (maximum size ≤2 cm) undergoing imaging surveillance.
Each participant should be likely to undergo ≥5 GBCA-enhanced MR examinations with the same GBCA at least annually throughout the 5-year study duration
Prospective participants with up to 3 well documented GBCA administrations prior to study screening are acceptable, provided that the imaging was performed with the same GBCA as the one to be prospectively used in the study. If the GBCA used cannot be identified, he/she cannot be enrolled.
Participants who never had and are not likely to receive any GBCA injection during the course of the study
Each control participant must be willing to undergo UE-MRI of the brain at baseline and at Year 5. In Years 1 to 4, the control participants will undergo their clinically indicated UE-MRIs, computed tomography (CT), ultrasound, or X-ray procedures
Exclusion
As evidenced by history or determined in the neurologic exam at screening, concurrent neurological and/or psychiatric disease (or treatments) that could influence the results of the study's motor and cognitive tests (e.g. Cerebrovascular disease, Multiple sclerosis, Neurodegenerative disease, Malignant disease other than listed in indications, Carcinoid tumors, Epilepsy, Prior neurosurgery, Psychotic disorders or any prior psychotic episode not otherwise specified - any documented prior history of chronic schizophrenia, Remittent or current medically confirmed major depressive disorder or bipolar disorder, History of long-term major depression or bipolar affective disorder with an active episode in the past 2 to 5 years, Neurodevelopmental disorders (eg, trisomy 21), Uncontrolled severe migraine, Uncontrolled or controlled anxiety or depression within 6 months before enrollment, Screening scores of ≤24 on the MMSE and/or ≥11 on the Hospital Anxiety and Depression Scale (HADS)).
Prior, planned, or ongoing chemotherapy or brain irradiation
Use of concomitant medication(s) affecting neuro-cognitive or motor function
Substance or alcohol abuse as determined by the investigator
Alcoholic cirrhosis
Renal disease, defined as estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2
History of environmental/occupational/other exposure to one or more chemicals that may affect cognitive and/or motor function, including, but not limited to, heavy metals (arsenic \[As\], cadmium \[Cd\], lead \[Pb\], manganese \[Mn\], and mercury \[Hg\]), pesticides, solvents, or carbon monoxide.
Clinical indications requiring \>1 contrast enhanced magnetic resonance imaging (CE-MRI) every 6 months
Pregnant or nursing (lactating) women
Presence of any metal-containing joint implants/prostheses
Participants with any previous exposure to a GBCA.
Participants with any contraindication to UE-MRI examinations.
What this trial measures
- Change of motor function from baseline to year 5 in comparison to a matched non-GBCA-exposed control groupAt 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 groupAt baseline, year 5
The endpoint is a composite z score, defined as the weighted sum of the z scores of the individual tests