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
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.
| Facility | City | Region | Status |
|---|---|---|---|
| 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| Yale University School of Medicine | New Haven | Connecticut | Withdrawn |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.
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