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RECRUITING
NCT04373564
PHASE4

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

View on ClinicalTrials.gov

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

PROCEDURE

Motor Tests

To assess motor function annually

PROCEDURE

Cognitive Tests

To assess cognitive function annually

PROCEDURE

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

PROCEDURE

Gadolinium Measurements

Blood samples and spontaneous urine specimens will be collected through the course of the study to measure Gd concentration

DRUG

Gadoxetate disodium

Administered as defined by the treating physician as part of routine clinical practice

DRUG

Gadobenate dimeglumine

Administered as defined by the treating physician as part of routine clinical practice

DRUG

Gadodiamide

Administered as defined by the treating physician as part of routine clinical practice

DRUG

Gadoterate meglumine

Administered as defined by the treating physician as part of routine clinical practice

DRUG

Gadobutrol

Administered as defined by the treating physician as part of routine clinical practice

DRUG

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