Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
Start Date
3/24/2021
Completion Date
12/31/2028
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.
Detailed Description
The primary objective of the study is to assess the potential effect of repeated exposure to either a linear or a macrocyclic gadolinium-based contrast agent (GBCA) on change from baseline to Year 5 in composite measure of motor and cognitive function among neurologically normal adults in comparison to a matched non-GBCA- exposed control group. 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.
Eligibility Criteria
Age Range: 18 years to 64 years
Interventions
Motor Tests
Cognitive Tests
Unenhanced-MRI of the brain
Gadolinium Measurements
Gadoxetate disodium
Gadobenate dimeglumine
Gadodiamide
Gadoterate meglumine
Gadobutrol
Gadoteridol
Conditions
Locations
Scottsdale Medical Imaging, LLC
Scottsdale, Arizona 85260
United States
Yale University School of Medicine
New Haven, Connecticut 06520
United States
University of Chicago Medical Center
Chicago, Illinois 60637
United States
Methodist Medical Center of Illinois
Peoria, Illinois 61637
United States
Massachussets General Hospital
Boston, Massachusetts 02114
United States
Boston University Medical Center
Boston, Massachusetts 02118
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
ActivMed Practices & Research, Inc.
Methuen, Massachusetts 01844
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts 01655
United States
Department of Radiology
St Louis, Missouri 63110
United States
UNC School of Medicine
Chapel Hill, North Carolina 27599
United States
Penn State Hershey Medical Center
Hershey, Pennsylvania 17033
United States
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania 19141
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
University of Wisconsin
Madison, Wisconsin 53792
United States
Hospital Santa Marta
Taguatinga, Federal District 72025-110
Brazil
Liga Norte-Rio-Grandense Contra o Câncer
Natal, Rio Grande do Norte 59075-740
Brazil
Instituto Mederi de Pesquisa e Saude
Passo Fundo, Rio Grande do Sul 99010-120
Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul 90035-001
Brazil
Instituto Baía Sul de Ensino e Pesquisa (IEP)
Florianópolis, Santa Catarina 88020-210
Brazil
CEMEC - Oncológica
São Bernardo do Campo, São Paulo 09715-090
Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo 15090-000
Brazil
CPCLIN - Centro de Pesquisas Clínicas Ltda.
São Paulo, São Paulo 01228-200
Brazil
Albert Einstein Sociedade Beneficente Israelita Brasileira
São Paulo, São Paulo 05652000
Brazil
CEMEC - Oncológica
São Bernardo do Campo,
Brazil
G. Kenneth Jansz Medical Professional Corporation
Burlington, Ontario L7N 3V2
Canada
Groupe Hospitalier Pitie-Salpetriere
Paris, 75013
France
CHU Strasbourg - Hôpital Hautepierre
Strasbourg, 67200
France
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg 72076
Germany
Vivantes Klinikum Neukoelln
Berlin, 12351
Germany
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, Siena 53100
Italy
Azienda Ospedaliera Universitaria di Trieste
Trieste, Trieste 34125
Italy
Ospedale San Raffaele
Milan, 20123
Italy
Università Campus Bio-Medico di Roma
Roma, 00128
Italy
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
Verona, 37134
Italy
BHI of Omsk region "Clinical Oncology Dispensary"
Omsk, 644013
Russia
FSBI "National medical scientific center of psychiatry and neurology n.a. V.M. Bekhterev" Adolescent
Saint Petersburg, 192019
Russia
FSBI North-West Federal Medical Research Center n.a. V.A. Almazov of MoH RF
Saint Petersburg, 197341
Russia
LLC Medical Center Mart
Saint Petersburg, 199178
Russia
RSBIH "Smolensk Regional Clinical Hospital"
Smolensk, 214019
Russia
Federal State Budgetary Scientific Institution "Tomsk National Research Medical Centre of the Russia
Tomsk, 634009
Russia
SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
Ufa, 450054
Russia
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do 24253
South Korea
Chonnam National University Hospital
Gwangju, Gyeonggi-do 61469
South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
South Korea
Inje University Busan Paik Hospital
Busan, 47392
South Korea
Pusan National University Hospital
Busan, 49241
South Korea
Chosun University Hospital
Gwangju, 61453
South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273
South Korea
Chung-Ang University Hospital
Seoul, 06973
South Korea