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Clinical Trials in the USA / NCT04373564
Recruiting Phase 4

Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years

NCT04373564 · tracked via the Priya Life Science USA tracker
Sponsor
Guerbet
Phase
Phase 4
Started
2021-03-24
Last updated
2026-01-22

Condition(s) studied

Motor FunctionCognitive FunctionContrast Media

Investigational drug(s) / intervention(s)

Motor TestsCognitive TestsUnenhanced-MRI of the brainGadolinium MeasurementsGadoxetate disodiumGadobenate dimeglumineGadodiamideGadoterate meglumineGadobutrolGadoteridol

Motor Tests: To assess motor function annually

Cognitive Tests: To assess cognitive function annually

Unenhanced-MRI of the brain: The UE-MRI of the brain will be performed at baseline and at the year 5 visit in order to exclude presence of a significant MRI abnormality

Gadolinium Measurements: Blood samples and spontaneous urine specimens will be collected through the course of the study to measure Gd concentration

Gadoxetate disodium: Administered as defined by the treating physician as part of routine clinical practice

Gadobenate dimeglumine: Administered as defined by the treating physician as part of routine clinical practice

Gadodiamide: Administered as defined by the treating physician as part of routine clinical practice

Gadoterate meglumine: Administered as defined by the treating physician as part of routine clinical practice

Gadobutrol: Administered as defined by the treating physician as part of routine clinical practice

Gadoteridol: Administered as defined by the treating physician as part of routine clinical practice

Study summary

This study is a postmarketing requirement jointly carried out by four NDA holders (Bayer AG, Bracco, GE Healthcare and Guerbet) and the CRO IQVIA.

The study aims to create detailed images of the organs and tissue of the human body during x-ray, CT-scan or MRI investigations, doctors are using contrast media (a kind of dye) which can be given to patients by injection into a blood vessel or by mouth.

In this study researchers want to find out whether so called gadolinium-based contrast agents (GBCAs) have an effect on body movement and mental skills when given to participants multiple times within 5 years.

The study plans to enroll about 2076 participants suffering from a condition for which they are likely to have at least annually a MRI or another imaging examinations. Only adults up to 65 years will be considered to join this study. During the study duration of 5 years participants will receive annually a MRI or other imaging tests (such as CT-scan, x-ray) and will visit the study doctor at least 7 times for physical examinations, laboratory investigations and tests on body movement and mental skills.

Eligibility

Sex
ALL
Min age
18 Years
Max age
64 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (51)

FacilityCityRegionStatus
Scottsdale Medical Imaging, LLC Scottsdale Arizona Recruiting
Yale University School of Medicine New Haven Connecticut Withdrawn
University of Chicago Medical Center Chicago Illinois Recruiting
Methodist Medical Center of Illinois Peoria Illinois Recruiting
Massachussets General Hospital Boston Massachusetts Recruiting
Boston University Medical Center Boston Massachusetts Terminated
Beth Israel Deaconess Medical Center Boston Massachusetts Withdrawn
ActivMed Practices & Research, Inc. Methuen Massachusetts Withdrawn
University of Massachusetts Memorial Medical Center Worcester Massachusetts Terminated
Department of Radiology St Louis Missouri Withdrawn
UNC School of Medicine Chapel Hill North Carolina Withdrawn
Penn State Hershey Medical Center Hershey Pennsylvania Recruiting
Albert Einstein Healthcare Network Philadelphia Pennsylvania Recruiting
UT Southwestern Medical Center Dallas Texas Recruiting
MD Anderson Cancer Center Houston Texas Withdrawn
University of Wisconsin Madison Wisconsin Recruiting
Hospital Santa Marta Taguatinga Federal District Terminated
Liga Norte-Rio-Grandense Contra o Câncer Natal Rio Grande do Norte Withdrawn
Instituto Mederi de Pesquisa e Saude Passo Fundo Rio Grande do Sul Recruiting
Hospital Moinhos de Vento Porto Alegre Rio Grande do Sul Recruiting
Instituto Baía Sul de Ensino e Pesquisa (IEP) Florianópolis Santa Catarina Withdrawn
CEMEC - Oncológica São Bernardo do Campo São Paulo Withdrawn
Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto São Paulo Recruiting
CPCLIN - Centro de Pesquisas Clínicas Ltda. São Paulo São Paulo Terminated
Albert Einstein Sociedade Beneficente Israelita Brasileira São Paulo São Paulo Recruiting
CEMEC - Oncológica São Bernardo do Campo Brazil Withdrawn
G. Kenneth Jansz Medical Professional Corporation Burlington Ontario Withdrawn
Groupe Hospitalier Pitie-Salpetriere Paris France Withdrawn
CHU Strasbourg - Hôpital Hautepierre Strasbourg France Recruiting
Universitaetsklinikum Tuebingen Tübingen Baden-Wurttemberg Active Not Recruiting
Vivantes Klinikum Neukoelln Berlin Germany Recruiting
A.O.U. Senese Policlinico Santa Maria alle Scotte Siena Siena Recruiting
Azienda Ospedaliera Universitaria di Trieste Trieste Trieste 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
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

+ 11 more sites — see the full list on the official registry below.

More Guerbet trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04373564 on ClinicalTrials.gov ↗ ← All trials in the USA