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Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
Sponsor: Guerbet
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.
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
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
2076
Start Date
2021-03-24
Completion Date
2028-12-31
Last Updated
2026-01-22
Healthy Volunteers
No
Interventions
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
Locations (51)
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 Câncer
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 Baía Sul de Ensino e Pesquisa (IEP)
Florianópolis, Santa Catarina, Brazil
CEMEC - Oncológica
São Bernardo do Campo, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
CPCLIN - Centro de Pesquisas Clínicas Ltda.
São Paulo, São Paulo, Brazil
Albert Einstein Sociedade Beneficente Israelita Brasileira
São Paulo, São Paulo, Brazil
CEMEC - Oncológica
São Bernardo do Campo, Brazil
G. Kenneth Jansz Medical Professional Corporation
Burlington, Ontario, Canada
Groupe Hospitalier Pitie-Salpetriere
Paris, France
CHU Strasbourg - Hôpital Hautepierre
Strasbourg, France
Universitaetsklinikum Tuebingen
Tübingen, 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
Università 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