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.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 2076 (estimated) |
| Sponsor | Guerbet Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 51 sites (Scottsdale, Arizona and 50 other locations) |
| Status | Recruiting |
| Started | March 24, 2021 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | January 22, 2026 |
| Trial ID | NCT04373564 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
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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
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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
- Study coordinator: Nathalie LE FUR, PhD
- Email: nathalie.lefur@guerbet.com
- Phone: +33649351166
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.