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Brief Title: Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
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
Study ID: NCT04373564
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
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, Saint 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, Distrito Federal, Brazil
Liga Norte-Rio-Grandense Contra o Câncer, Natal, Rio Grande Do Norte, Brazil
Instituto Mederi de Pesquisa e Saude, Passo Fundo, RS, Brazil
Hospital Moinhos de Vento, Porto Alegre, RS, Brazil
Instituto Baía Sul de Ensino e Pesquisa (IEP), Florianopolis, Santa Catarina, Brazil
CEMEC - Oncológica, São Bernardo do Campo, Sao Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José Do Rio Preto, SP, Brazil
CPCLIN - Centro de Pesquisas Clínicas Ltda., São Paulo, SP, Brazil
Albert Einstein Sociedade Beneficente Israelita Brasileira, São Paulo, SP, Brazil
CEMEC - Oncológica, Sao 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, Tuebingen, Baden Wuerttemberg, Germany
A.O.U. Senese Policlinico Santa Maria alle Scotte, Siena, , Italy
Azienda Ospedaliera Universitaria di Trieste, Trieste, , Italy
Hallym University Chuncheon Sacred Heart Hospital, Chuncheon, Gangwon-do, Korea, Republic of
Chonnam National University Hospital, Gwangju, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
Inje University Busan Paik Hospital, Busan, , Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
Chosun University Hospital, Gwangju, , Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Chung-Ang University Hospital, Seoul, , Korea, Republic of
BHI of Omsk region "Clinical Oncology Dispensary", Omsk, , Russian Federation
FSBI "National medical scientific center of psychiatry and neurology n.a. V.M. Bekhterev" Adolescent, Saint-Petersburg, , Russian Federation
FSBI North-West Federal Medical Research Center n.a. V.A. Almazov of MoH RF, Saint-Petersburg, , Russian Federation
LLC Medical Center Mart, Saint-Petersburg, , Russian Federation
RSBIH "Smolensk Regional Clinical Hospital", Smolensk, , Russian Federation
Federal State Budgetary Scientific Institution "Tomsk National Research Medical Centre of the Russia, Tomsk, , Russian Federation
SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan, Ufa, , Russian Federation