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MRI dye safety under scrutiny: landmark study tracks brain effects over 5 years

NCT ID NCT04373564

Knowledge-focused Sponsor: Guerbet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether repeated doses of a gadolinium-based contrast agent (a dye used in MRI scans) affect motor and cognitive functions in healthy adults. About 2076 participants will receive annual imaging and undergo tests over 5 years. The goal is to compare changes in movement and thinking between those who get the dye and those who do not.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 2,076 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm colorectal cancer colorectal neoplasm hepatocellular carcinoma liver disorder neuroendocrine neoplasm pancreatic intraductal papillary-mucinous neoplasm prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cognitive function Contrast media Motor function

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    32 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O.U. Senese Policlinico Santa Maria alle Scotte

    RECRUITING

    Siena, Siena, 53100, Italy

  • ActivMed Practices & Research, Inc.

    WITHDRAWN

    Methuen, Massachusetts, 01844, United States

  • Albert Einstein Healthcare Network

    RECRUITING

    Philadelphia, Pennsylvania, 19141, United States

  • Albert Einstein Sociedade Beneficente Israelita Brasileira

    RECRUITING

    São Paulo, São Paulo, 05652000, Brazil

  • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)

    RECRUITING

    Verona, 37134, Italy

  • Azienda Ospedaliera Universitaria di Trieste

    RECRUITING

    Trieste, Trieste, 34125, Italy

  • BHI of Omsk region "Clinical Oncology Dispensary"

    SUSPENDED

    Omsk, 644013, Russia

  • Beth Israel Deaconess Medical Center

    WITHDRAWN

    Boston, Massachusetts, 02215, United States

  • Boston University Medical Center

    TERMINATED

    Boston, Massachusetts, 02118, United States

  • CEMEC - Oncológica

    WITHDRAWN

    São Bernardo do Campo, São Paulo, 09715-090, Brazil

  • CEMEC - Oncológica

    WITHDRAWN

    São Bernardo do Campo, Brazil

  • CHU Strasbourg - Hôpital Hautepierre

    RECRUITING

    Strasbourg, 67200, France

  • CPCLIN - Centro de Pesquisas Clínicas Ltda.

    TERMINATED

    São Paulo, São Paulo, 01228-200, Brazil

  • Chonnam National University Hospital

    WITHDRAWN

    Gwangju, Gyeonggi-do, 61469, South Korea

  • Chosun University Hospital

    RECRUITING

    Gwangju, 61453, South Korea

  • Chung-Ang University Hospital

    RECRUITING

    Seoul, 06973, South Korea

  • Department of Radiology

    WITHDRAWN

    St Louis, Missouri, 63110, United States

  • FSBI "National medical scientific center of psychiatry and neurology n.a. V.M. Bekhterev" Adolescent

    SUSPENDED

    Saint Petersburg, 192019, Russia

  • FSBI North-West Federal Medical Research Center n.a. V.A. Almazov of MoH RF

    SUSPENDED

    Saint Petersburg, 197341, Russia

  • Federal State Budgetary Scientific Institution "Tomsk National Research Medical Centre of the Russia

    SUSPENDED

    Tomsk, 634009, Russia

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    RECRUITING

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • G. Kenneth Jansz Medical Professional Corporation

    WITHDRAWN

    Burlington, Ontario, L7N 3V2, Canada

  • Gangnam Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 06273, South Korea

  • Groupe Hospitalier Pitie-Salpetriere

    WITHDRAWN

    Paris, 75013, France

  • Hallym University Chuncheon Sacred Heart Hospital

    WITHDRAWN

    Chuncheon, Gangwon-do, 24253, South Korea

  • Hospital Moinhos de Vento

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

  • Hospital Santa Marta

    TERMINATED

    Taguatinga, Federal District, 72025-110, Brazil

  • Inje University Busan Paik Hospital

    RECRUITING

    Busan, 47392, South Korea

  • Instituto Baía Sul de Ensino e Pesquisa (IEP)

    WITHDRAWN

    Florianópolis, Santa Catarina, 88020-210, Brazil

  • Instituto Mederi de Pesquisa e Saude

    RECRUITING

    Passo Fundo, Rio Grande do Sul, 99010-120, Brazil

  • LLC Medical Center Mart

    SUSPENDED

    Saint Petersburg, 199178, Russia

  • Liga Norte-Rio-Grandense Contra o Câncer

    WITHDRAWN

    Natal, Rio Grande do Norte, 59075-740, Brazil

  • MD Anderson Cancer Center

    WITHDRAWN

    Houston, Texas, 77030, United States

  • Massachussets General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Methodist Medical Center of Illinois

    RECRUITING

    Peoria, Illinois, 61637, United States

  • Ospedale San Raffaele

    RECRUITING

    Milan, 20123, Italy

  • Penn State Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Pusan National University Hospital

    RECRUITING

    Busan, 49241, South Korea

  • RSBIH "Smolensk Regional Clinical Hospital"

    SUSPENDED

    Smolensk, 214019, Russia

  • SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

    SUSPENDED

    Ufa, 450054, Russia

  • Scottsdale Medical Imaging, LLC

    RECRUITING

    Scottsdale, Arizona, 85260, United States

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • UNC School of Medicine

    WITHDRAWN

    Chapel Hill, North Carolina, 27599, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Universitaetsklinikum Tuebingen

    ACTIVE_NOT_RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Massachusetts Memorial Medical Center

    TERMINATED

    Worcester, Massachusetts, 01655, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Università Campus Bio-Medico di Roma

    RECRUITING

    Roma, 00128, Italy

  • Vivantes Klinikum Neukoelln

    RECRUITING

    Berlin, 12351, Germany

  • Yale University School of Medicine

    WITHDRAWN

    New Haven, Connecticut, 06520, United States

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Other studies related to the condition(s) this trial covers.