Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years

PHASE4RecruitingINTERVENTIONAL
Enrollment

2,076

Participants

Timeline

Start Date

March 24, 2021

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Motor FunctionCognitive FunctionContrast Media
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

Trial Locations (47)

13620

RECRUITING

Seoul National University Bundang Hospital, Seongnam-si

17033

RECRUITING

Penn State Hershey Medical Center, Hershey

19141

RECRUITING

Albert Einstein Healthcare Network, Philadelphia

24253

RECRUITING

Hallym University Chuncheon Sacred Heart Hospital, Chuncheon

27599

RECRUITING

UNC School of Medicine, Chapel Hill

34125

RECRUITING

Azienda Ospedaliera Universitaria di Trieste, Trieste

47392

RECRUITING

Inje University Busan Paik Hospital, Busan

49241

RECRUITING

Pusan National University Hospital, Busan

53100

RECRUITING

A.O.U. Senese Policlinico Santa Maria alle Scotte, Siena

53792

RECRUITING

University of Wisconsin, Madison

60637

RECRUITING

University of Chicago Medical Center, Chicago

61453

RECRUITING

Chosun University Hospital, Gwangju

61469

RECRUITING

Chonnam National University Hospital, Gwangju

61637

RECRUITING

Methodist Medical Center of Illinois, Peoria

63110

WITHDRAWN

Department of Radiology, St Louis

67200

RECRUITING

CHU Strasbourg - Hôpital Hautepierre, Strasbourg

72076

ACTIVE_NOT_RECRUITING

Universitaetsklinikum Tuebingen, Tübingen

75013

WITHDRAWN

Groupe Hospitalier Pitie-Salpetriere, Paris

75390

RECRUITING

UT Southwestern Medical Center, Dallas

77030

NOT_YET_RECRUITING

MD Anderson Cancer Center, Houston

85260

RECRUITING

Scottsdale Medical Imaging, LLC, Scottsdale

192019

SUSPENDED

"FSBI National medical scientific center of psychiatry and neurology n.a. V.M. Bekhterev Adolescent", Saint Petersburg

197341

SUSPENDED

FSBI North-West Federal Medical Research Center n.a. V.A. Almazov of MoH RF, Saint Petersburg

199178

SUSPENDED

LLC Medical Center Mart, Saint Petersburg

214019

SUSPENDED

"RSBIH Smolensk Regional Clinical Hospital", Smolensk

450054

SUSPENDED

SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan, Ufa

634009

SUSPENDED

"Federal State Budgetary Scientific Institution Tomsk National Research Medical Centre of the Russia", Tomsk

644013

SUSPENDED

"BHI of Omsk region Clinical Oncology Dispensary", Omsk

06520

WITHDRAWN

Yale University School of Medicine, New Haven

02114

RECRUITING

Massachussets General Hospital, Boston

02118

RECRUITING

Boston University Medical Center, Boston

02215

RECRUITING

Beth Israel Deaconess Medical Center, Boston

01844

RECRUITING

ActivMed Practices & Research, Inc., Methuen

01655

RECRUITING

University of Massachusetts Memorial Medical Center, Worcester

72025-110

TERMINATED

Hospital Santa Marta, Taguatinga

59075-740

RECRUITING

Liga Norte-Rio-Grandense Contra o Câncer, Natal

99010-120

RECRUITING

Instituto Mederi de Pesquisa e Saude, Passo Fundo

90035-001

RECRUITING

Hospital Moinhos de Vento, Porto Alegre

88020-210

RECRUITING

Instituto Baía Sul de Ensino e Pesquisa (IEP), Florianópolis

09715-090

RECRUITING

CEMEC - Oncológica, São Bernardo do Campo

15090-000

RECRUITING

Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José do Rio Preto

01228-200

RECRUITING

CPCLIN - Centro de Pesquisas Clínicas Ltda., São Paulo

05652000

RECRUITING

Albert Einstein Sociedade Beneficente Israelita Brasileira, São Paulo

Unknown

WITHDRAWN

CEMEC - Oncológica, São Bernardo do Campo

L7N 3V2

WITHDRAWN

G. Kenneth Jansz Medical Professional Corporation, Burlington

06273

RECRUITING

Gangnam Severance Hospital, Yonsei University Health System, Seoul

06973

RECRUITING

Chung-Ang University Hospital, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Bayer AG (Sponsor)

UNKNOWN

collaborator

Bracco (Sponsor)

UNKNOWN

collaborator

GEHC (Sponsor)

UNKNOWN

lead

Guerbet

INDUSTRY

NCT04373564 - Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years | Biotech Hunter | Biotech Hunter