Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
NCT ID: NCT04373564
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
2076 participants
INTERVENTIONAL
2021-03-24
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Known or Suspected Brain or Spinal Cord-related Problems
NCT05915702
Study to Find the Appropriate Dose of a New Gadolinium-based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions
NCT04307186
Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
NCT03996447
An Observational Study to Collect Information on the Safety of Gadolinium-Based Contrast Agents in Patients in India
NCT06257277
Post-marketing Safety Study in Participants of All Pathologies Who Receive Gadolinium-Based Contrast Agents (GBCAs) for Contrast-Enhanced Magnetic Resonance Imaging (MR) Examination
NCT03455283
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The secondary objectives comprise the assessment of the following endpoints in GBCA-exposed participants as compared to controls a) changes from baseline in composite measure of motor and cognitive function post-baseline on yearly basis (Years 1 to 4); b) changes from baseline in each individual test of motor and cognitive function on yearly basis (Years 1 to 5). Total Gd concentrations in blood and urine samples on yearly basis (Years 1 to 5) and adverse events will be collected as secondary objectives.
Of note : The study is considered interventional because of the addition of UE-MRI scans for all participants, as well as blood sampling and the administration of the motor and cognitive tests. The GBCA administered as part of the contrast-enhanced MR imaging in the experimental arms is not the intervention in this study. Neither the protocol nor the investigators assign patients to a specific GBCA as part of the study, making this part of the study observational rather than interventional. The participants were already scheduled, prior to study screening, to undergo CE-MRI as part of their clinical care. The choice of GBCA for the CE-MRI will be based on medical need and institutional usage of GBCA, independent of study participation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Linear GBCAs
Adult participants, who were scheduled for repeated enhanced magnetic resonance imaging (MRI), receive a linear gadoliniumbased contrast agent (GBCA, i.e. Eovist/ Primovist, MultiHance or Omniscan) prior to MRI. Each participant will receive the same GBCA throughout the study.
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
Macrocyclic GBCAs
Adult participants, who were scheduled for repeated enhanced magnetic resonance imaging (MRI), receive a macrocyclic gadolinium-based contrast agent (GBCA, i.e. Gadavist/ Gadovist, Dotarem, Magnescope or ProHance) prior to MRI. Each participant will receive the same GBCA throughout the study.
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
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
No GBCA (Control arm)
Adult participants who were never exposed to any gadolinium-based contrast agent and matching the population characteristics of the two GBCA arms. They will not receive any gadolinium-based contrast agent over the study course, but may undergo clinically indicated imaging (e.g. unenhanced magnetic resonance imaging (MRI), unenhanced or enhanced computed tomography, ultrasound and/or X-ray).
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 ā¤2 cm) undergoing imaging surveillance.
In addition, for participants in the GBCA Arms only:
* Each participant should be likely to undergo ā„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
* 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.
18 Years
64 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer AG (Sponsor)
UNKNOWN
Bracco (Sponsor)
UNKNOWN
GEHC (Sponsor)
UNKNOWN
Guerbet
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Scottsdale Medical Imaging, LLC
Scottsdale, Arizona, United States
Yale University School of Medicine
New Haven, Connecticut, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Massachussets General Hospital
Boston, Massachusetts, United States
Boston University Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
ActivMed Practices & Research, Inc.
Methuen, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Department of Radiology
St Louis, Missouri, United States
UNC School of Medicine
Chapel Hill, North Carolina, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
Hospital Santa Marta
Taguatinga, Federal District, Brazil
Liga Norte-Rio-Grandense Contra o CĆ¢ncer
Natal, Rio Grande do Norte, Brazil
Instituto Mederi de Pesquisa e Saude
Passo Fundo, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Instituto BaĆa Sul de Ensino e Pesquisa (IEP)
FlorianĆ³polis, Santa Catarina, Brazil
CEMEC - OncolĆ³gica
SĆ£o Bernardo do Campo, SĆ£o Paulo, Brazil
FundaĆ§Ć£o Faculdade Regional de Medicina de SĆ£o JosĆ© do Rio Preto
SĆ£o JosĆ© do Rio Preto, SĆ£o Paulo, Brazil
CPCLIN - Centro de Pesquisas ClĆnicas Ltda.
SĆ£o Paulo, SĆ£o Paulo, Brazil
Albert Einstein Sociedade Beneficente Israelita Brasileira
SĆ£o Paulo, SĆ£o Paulo, Brazil
CEMEC - OncolĆ³gica
SĆ£o Bernardo do Campo, , Brazil
G. Kenneth Jansz Medical Professional Corporation
Burlington, Ontario, Canada
Groupe Hospitalier Pitie-Salpetriere
Paris, , France
CHU Strasbourg - HĆ“pital Hautepierre
Strasbourg, , France
Universitaetsklinikum Tuebingen
TĆ¼bingen, Baden-Wurttemberg, Germany
Vivantes Klinikum Neukoelln
Berlin, , Germany
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, Siena, Italy
Azienda Ospedaliera Universitaria di Trieste
Trieste, Trieste, Italy
Ospedale San Raffaele
Milan, , Italy
UniversitĆ Campus Bio-Medico di Roma
Roma, , Italy
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
Verona, , Italy
BHI of Omsk region "Clinical Oncology Dispensary"
Omsk, , Russia
FSBI "National medical scientific center of psychiatry and neurology n.a. V.M. Bekhterev" Adolescent
Saint Petersburg, , Russia
FSBI North-West Federal Medical Research Center n.a. V.A. Almazov of MoH RF
Saint Petersburg, , Russia
LLC Medical Center Mart
Saint Petersburg, , Russia
RSBIH "Smolensk Regional Clinical Hospital"
Smolensk, , Russia
Federal State Budgetary Scientific Institution "Tomsk National Research Medical Centre of the Russia
Tomsk, , Russia
SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
Ufa, , Russia
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, South Korea
Chonnam National University Hospital
Gwangju, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Chosun University Hospital
Gwangju, , South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: primary
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20405
Identifier Type: OTHER
Identifier Source: secondary_id
GMRA-105
Identifier Type: OTHER
Identifier Source: secondary_id
GE-041-081
Identifier Type: OTHER
Identifier Source: secondary_id
IQVIA-ODYS-001-LZA45541
Identifier Type: OTHER
Identifier Source: secondary_id
DGD-44-065
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.