account_circleRecruiting

Motor Function / Cognitive Function / Contrast Media

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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - 64 Years

Trial summary

Enrollment Goal
2076
Trial Dates
March 2021 - December 2028
Phase
Phase 4
Could I Receive a placebo
No
Products
Eovist/Primovist (Gadoxetate disodium, BAY86-4873)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many LocationsMany Locations, 27599, United States
Recruiting
Many LocationsMany Locations, Korea, Republic Of
Recruiting
Many LocationsMany Locations, 02114-2696, United States
Recruiting
Many LocationsMany Locations, 17033, United States
Recruiting
Many LocationsMany Locations, 75390, United States
Recruiting
Many LocationsMany Locations, 53792, United States
Recruiting
Many LocationsMany Locations, 61637, United States
Recruiting
Many LocationsMany Locations, 85260, United States
Recruiting
Many LocationsMany Locations, Brazil
Suspended
Many LocationsMany Locations, Russian Federation
Recruiting
Many LocationsMany Locations, Italy
Recruiting
Sao Jose Rio Preto, 15090-000, Brazil
Recruiting
Instituto Mederi de Pesquisa e SaudePasso Fundo, 99010-120, Brazil
Recruiting
Hospital Moinhos de Vento-Centro ClínicoPorto Alegre, 90035-001, Brazil
Terminated
CPCLIN - Centro de Pesquisas Clínicas Ltda.Sao Paulo, 01228-200, Brazil
Recruiting
Albert Einstein Sociedade Beneficente Israelita BrasileiraSão Paulo, 05652000, Brazil
Withdrawn
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa ClínicaNatal, 59075-740, Brazil
Withdrawn
CEMEC CTOBelem, 66053-000, Brazil
Withdrawn
Instituto Baía Sul de Ensino e Pesquisa (IEP)Florianopolis, 88020-210, Brazil
Terminated
Hospital Santa MartaTaguatinga, 72025-110, Brazil
Recruiting
Gangnam Severance Hospital, Yonsei University Health SystemSeoul, 6273, Korea,_republic_of
Recruiting
Chosun University HospitalGwangju, 61453, Korea,_republic_of
Withdrawn
Ulsan University HospitalUlsan, 44033, Korea,_republic_of
Recruiting
Inje University Busan Paik HospitalBusan, 47392, Korea,_republic_of
Recruiting
Chung-Ang University HospitalSeoul, 156-755, Korea,_republic_of
Recruiting
Pusan National University HospitalBusan, 49241, Korea,_republic_of
Not yet recruiting
Seoul National University Bundang HospitalSeongnam-si, 13620, Korea,_republic_of
Withdrawn
APHP-Hopital la Pitie SalpetrierePARIS, 75634, France
Withdrawn
Centre Hospitalier de la Région d’AnnecyMetz-Tessy, 74370, France
Suspended
Clinical Oncological Dispensary of Omsk RegionOmsk, 644013, Russia
Recruiting
Vivantes Klinikum NeuköllnBerlin, 12351, Germany
Not yet recruiting
Universitaets Klinikum Frankfurt (Klinikum der Johann Wolfgang Goethe-Universitaet)Frankfurt am Main, 60596, Germany
Not yet recruiting
Klinikum der Universität München Grosshadern - Klinik/Poliklinik Radiologie LMU KlinikumMünchen, 21377, Germany
Not yet recruiting
Universitaetsklinikum KoelnKoeln, 50937, Germany
Not yet recruiting
Azienda Ospedaliera Universitaria Integrata VeronaVerona, 37134, Italy
Not yet recruiting
University Hospital Of Ferrara - Radiologia UniversitariaFerrara, 44124, Italy
Recruiting
Azienda Sanitaria Universitaria Giuliano Isontina - OncologiaTrieste, 34149, Italy
Not yet recruiting
Fondazione Policlinico Universitario Campus Bio-medico - Diagnostica per ImmaginiRoma, 00128, Italy
Not yet recruiting
Azienda Ospedaliera Universitaria Senese - Neuroradiologia diagnostica e terapeuticaSiena, 53100, Italy
Recruiting
Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia ProvincialeReggio Emilia, 42123, Italy
Not yet recruiting
Ospedale San Raffaele s.r.l. - Oncologia MedicaMilano, 20132, Italy
Not yet recruiting
Ospedale San Raffaele s.r.l. - Oncologia MedicaMilano, 20132, Italy
Not yet recruiting
Istituto Europeo di Oncologia s.r.lMilano, 20141, Italy
Not yet recruiting
Loyola University Medical Center - RadiologyMaywood, 60153, United States
Withdrawn
Chonnam National University HospitalDong-gu, Gwangju, 61469, Korea,_republic_of

Primary Outcome

  • Change of motor function from baseline to year 5 in comparison to a matched non-GBCA-exposed control group
    The endpoint is a composite z score, defined as the weighted sum of the z scores of the individual tests.
    date_rangeTime Frame:
    At baseline, year 5
  • Change in cognitive function from baseline to year 5 in comparison to a matched non-GBCA-exposed control group
    The endpoint is a composite z score, defined as the weighted sum of the z scores of the individual tests.
    date_rangeTime Frame:
    At baseline, year 5

Secondary Outcome

  • Change from baseline in the composite endpoints (motor and cognitive) at each of the post-baseline time points (Years 1 to 4) in GBCA-exposed participants as compared to controls
    The endpoint is a composite z score, defined as the weighted sum of the z scores of the individual tests.
    date_rangeTime Frame:
    At baseline, years 1, 2, 3, 4
  • Change from baseline for each of the individual tests (motor and cognitive) at each of the post-baseline time points (Years 1 to 5) in GBCA-exposed participants as compared to controls
    The endpoint is a composite z score, defined as the weighted sum of the z scores of the individual tests.
    date_rangeTime Frame:
    At baseline, years 1, 2, 3, 4
  • Number of participants with adverse events
    date_rangeTime Frame:
    At baseline, years 1, 2, 3, 4, 5
  • Total Gd concentrations (as measured in a central laboratory) in blood and urine samples taken from exposed and control participants at the time of the annual visit
    date_rangeTime Frame:
    At baseline, years 1, 2, 3, 4 and 5

Trial design

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
Trial Type
Interventional
Intervention Type
Procedure/Surgery
Trial Purpose
Other
Allocation
Non-randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
3