Clinical trial Recruiting at 25 sites Phase 4 Interventional Ages 18 to 64

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

Official title: 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

Run by Guerbet · NCT04373564 · Data updated 2026-11-12

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

More Cognitive Function trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 64 Years
SexAll
Enrollment2076 (estimated)
SponsorGuerbet
Industry-sponsored
Drugs / interventionschemotherapy
Locations51 sites (Scottsdale, Arizona and 50 other locations)
StatusRecruiting
StartedMarch 24, 2021
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedJanuary 22, 2026
Trial IDNCT04373564 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients with unstable neurologic or psychiatric diseases may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

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 it's running

  • Scottsdale Medical Imaging, LLC
    Scottsdale, Arizona, United States
    Recruiting
  • University of Chicago Medical Center
    Chicago, Illinois, United States
    Recruiting
  • Methodist Medical Center of Illinois
    Peoria, Illinois, United States
    Recruiting
  • Massachussets General Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Penn State Hershey Medical Center
    Hershey, Pennsylvania, United States
    Recruiting
  • Albert Einstein Healthcare Network
    Philadelphia, Pennsylvania, United States
    Recruiting
Show 44 more locations
  • UT Southwestern Medical Center
    Dallas, Texas, United States
    Recruiting
  • University of Wisconsin
    Madison, Wisconsin, United States
    Recruiting
  • Instituto Mederi de Pesquisa e Saude
    Passo Fundo, Rio Grande do Sul, Brazil
    Recruiting
  • Hospital Moinhos de Vento
    Porto Alegre, Rio Grande do Sul, Brazil
    Recruiting
  • Fundação Faculdade Regional de Medicina de São José do Rio Preto
    São José do Rio Preto, São Paulo, Brazil
    Recruiting
  • Albert Einstein Sociedade Beneficente Israelita Brasileira
    São Paulo, São Paulo, Brazil
    Recruiting
  • CHU Strasbourg - Hôpital Hautepierre
    Strasbourg, France
    Recruiting
  • Vivantes Klinikum Neukoelln
    Berlin, Germany
    Recruiting
  • A.O.U. Senese Policlinico Santa Maria alle Scotte
    Siena, Siena, Italy
    Recruiting
  • Azienda Ospedaliera Universitaria di Trieste
    Trieste, Trieste, Italy
    Recruiting
  • Ospedale San Raffaele
    Milan, Italy
    Recruiting
  • Università Campus Bio-Medico di Roma
    Roma, Italy
    Recruiting
  • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
    Verona, Italy
    Recruiting
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do, South Korea
    Recruiting
  • Inje University Busan Paik Hospital
    Busan, South Korea
    Recruiting
  • Pusan National University Hospital
    Busan, South Korea
    Recruiting
  • Chosun University Hospital
    Gwangju, South Korea
    Recruiting
  • Gangnam Severance Hospital, Yonsei University Health System
    Seoul, South Korea
    Recruiting
  • Chung-Ang University Hospital
    Seoul, South Korea
    Recruiting
  • Yale University School of Medicine
    New Haven, Connecticut, United States
    Withdrawn
  • Boston University Medical Center
    Boston, Massachusetts, United States
    Terminated
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts, United States
    Withdrawn
  • ActivMed Practices & Research, Inc.
    Methuen, Massachusetts, United States
    Withdrawn
  • University of Massachusetts Memorial Medical Center
    Worcester, Massachusetts, United States
    Terminated
  • Department of Radiology
    St Louis, Missouri, United States
    Withdrawn
  • UNC School of Medicine
    Chapel Hill, North Carolina, United States
    Withdrawn
  • MD Anderson Cancer Center
    Houston, Texas, United States
    Withdrawn
  • Hospital Santa Marta
    Taguatinga, Federal District, Brazil
    Terminated
  • Liga Norte-Rio-Grandense Contra o Câncer
    Natal, Rio Grande do Norte, Brazil
    Withdrawn
  • Instituto Baía Sul de Ensino e Pesquisa (IEP)
    Florianópolis, Santa Catarina, Brazil
    Withdrawn
  • CEMEC - Oncológica
    São Bernardo do Campo, São Paulo, Brazil
    Withdrawn
  • CPCLIN - Centro de Pesquisas Clínicas Ltda.
    São Paulo, São Paulo, Brazil
    Terminated
  • CEMEC - Oncológica
    São Bernardo do Campo, Brazil
    Withdrawn
  • G. Kenneth Jansz Medical Professional Corporation
    Burlington, Ontario, Canada
    Withdrawn
  • Groupe Hospitalier Pitie-Salpetriere
    Paris, France
    Withdrawn
  • Universitaetsklinikum Tuebingen
    Tübingen, Baden-Wurttemberg, Germany
    Active not recruiting
  • BHI of Omsk region "Clinical Oncology Dispensary"
    Omsk, Russia
    Suspended
  • FSBI "National medical scientific center of psychiatry and neurology n.a. V.M. Bekhterev" Adolescent
    Saint Petersburg, Russia
    Suspended
  • FSBI North-West Federal Medical Research Center n.a. V.A. Almazov of MoH RF
    Saint Petersburg, Russia
    Suspended
  • LLC Medical Center Mart
    Saint Petersburg, Russia
    Suspended
  • RSBIH "Smolensk Regional Clinical Hospital"
    Smolensk, Russia
    Suspended
  • Federal State Budgetary Scientific Institution "Tomsk National Research Medical Centre of the Russia
    Tomsk, Russia
    Suspended
  • SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
    Ufa, Russia
    Suspended
  • Hallym University Chuncheon Sacred Heart Hospital
    Chuncheon, Gangwon-do, South Korea
    Withdrawn

+1 more sites. See ClinicalTrials.gov for the full list.

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.