Home › Trials › NCT04373564

Effects of Gadolinium-based Contrast Media on Movement and Mental Skills

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

Phase 4 Interventional Guerbet · NCT04373564

This study is testing how repeated use of gadolinium-based contrast agents during imaging tests affects movement and thinking skills in healthy adults.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment2076 (estimated)
Ages18 Years to 64 Years
SexAll
SponsorGuerbet Industry-sponsored
Drugs / interventionschemotherapy
Locations51 sites (Scottsdale, Arizona and 50 other locations)
Trial IDNCT04373564 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of repeated exposure to gadolinium-based contrast agents (GBCAs) on motor and cognitive functions in neurologically normal adults who are scheduled for MRI or other imaging tests. Over a period of five years, approximately 2076 participants will undergo annual imaging examinations and assessments of their motor and cognitive skills. The study aims to compare the performance of participants exposed to GBCAs with a matched control group that has not been exposed. Additionally, blood and urine samples will be collected to measure gadolinium concentrations and monitor any adverse events.

Who should consider this trial

Good fit: Ideal candidates for this study are neurologically normal adults up to 65 years old who require annual MRI or other imaging examinations for specific medical conditions.

Not a fit: Patients with unstable neurologic or psychiatric diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the safety and effects of gadolinium-based contrast agents on cognitive and motor functions, potentially influencing clinical practices for imaging procedures.

How similar studies have performed: While there have been studies on the effects of GBCAs, this specific approach assessing long-term cognitive and motor function changes is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 neoplasm (IPMN) of the pancreas (maximum size ≤2 cm) undergoing imaging surveillance.

In addition, for participants in the GBCA Arms only:

* 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.

For the Control Arm:

* 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 Criteria:

* 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

In addition, for participants in either of the GBCA Arms only:

\- Receipt of a GBCA or generic prior to study entry other than the specific GBCA to be administered during the course of the study.

For participants in the Control Arm only:

* Participants with any previous exposure to a GBCA.
* Participants with any contraindication to UE-MRI examinations.

Where this trial is running

Scottsdale, Arizona and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Motor FunctionCognitive FunctionContrast MediaMotor function assessmentCognitive function assessmentMagnetic Resonance ImagingGadoliniumGadolinium-based contrast agent
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.