Actively Recruiting
Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
Led by Guerbet · Updated on 2026-01-22
2076
Participants Needed
51
Research Sites
405 weeks
Total Duration
On this page
Sponsors
G
Guerbet
Lead Sponsor
B
Bayer AG (Sponsor)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be neurologically normal, confirmed by a normal neurologic exam at screening
- Participant agrees to have unenhanced MRI of the brain at enrollment and at 5 years
- Participants must have one of the following: medium to high breast cancer risk or dense breasts needing MRI screening, elevated PSA under prostate cancer surveillance, chronic liver disease for liver cancer surveillance, low-grade colorectal or neuroendocrine tumors for liver metastases screening, or small pancreatic IPMN under imaging surveillance
- GBCA-exposed participants should likely have at least 5 GBCA-enhanced MRI exams annually with the same GBCA over 5 years
- Participants with up to 3 prior documented GBCA administrations with the same GBCA are eligible
- Control participants must have no prior or planned GBCA exposure during the study
- Control participants must be willing to undergo unenhanced brain MRI at baseline and year 5 and clinical imaging as needed in years 1 to 4
You will not qualify if you...
- History or current neurological or psychiatric diseases affecting motor or cognitive tests, including cerebrovascular disease, multiple sclerosis, neurodegenerative diseases, malignant diseases other than listed, carcinoid tumors, epilepsy, prior neurosurgery, psychotic disorders, major depression or bipolar disorder within recent years, neurodevelopmental disorders, uncontrolled severe migraine, recent anxiety or depression, or low cognitive screening scores
- Prior, planned, or ongoing chemotherapy or brain irradiation
- Use of medications affecting neuro-cognitive or motor function
- Substance or alcohol abuse
- Alcoholic cirrhosis
- Kidney disease with eGFR less than 60 mL/min/1.73 m2
- Exposure to chemicals affecting cognitive or motor function such as heavy metals, pesticides, solvents, or carbon monoxide
- Need for more than one contrast-enhanced MRI every 6 months
- Pregnant or nursing women
- Presence of metal-containing joint implants or prostheses
- For GBCA arms: prior receipt of a different GBCA before study entry
- For control arm: any prior GBCA exposure or contraindications to unenhanced MRI examinations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 51 locations
1
Scottsdale Medical Imaging, LLC
Scottsdale, Arizona, United States, 85260
Actively Recruiting
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Withdrawn
3
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
4
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61637
Actively Recruiting
5
Massachussets General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Terminated
7
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Withdrawn
8
ActivMed Practices & Research, Inc.
Methuen, Massachusetts, United States, 01844
Withdrawn
9
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Terminated
10
Department of Radiology
St Louis, Missouri, United States, 63110
Withdrawn
11
UNC School of Medicine
Chapel Hill, North Carolina, United States, 27599
Withdrawn
12
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
13
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, United States, 19141
Actively Recruiting
14
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
15
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Withdrawn
16
University of Wisconsin
Madison, Wisconsin, United States, 53792
Actively Recruiting
17
Hospital Santa Marta
Taguatinga, Federal District, Brazil, 72025-110
Terminated
18
Liga Norte-Rio-Grandense Contra o Câncer
Natal, Rio Grande do Norte, Brazil, 59075-740
Withdrawn
19
Instituto Mederi de Pesquisa e Saude
Passo Fundo, Rio Grande do Sul, Brazil, 99010-120
Actively Recruiting
20
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
Actively Recruiting
21
Instituto Baía Sul de Ensino e Pesquisa (IEP)
Florianópolis, Santa Catarina, Brazil, 88020-210
Withdrawn
22
CEMEC - Oncológica
São Bernardo do Campo, São Paulo, Brazil, 09715-090
Withdrawn
23
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
24
CPCLIN - Centro de Pesquisas Clínicas Ltda.
São Paulo, São Paulo, Brazil, 01228-200
Terminated
25
Albert Einstein Sociedade Beneficente Israelita Brasileira
São Paulo, São Paulo, Brazil, 05652000
Actively Recruiting
26
CEMEC - Oncológica
São Bernardo do Campo, Brazil
Withdrawn
27
G. Kenneth Jansz Medical Professional Corporation
Burlington, Ontario, Canada, L7N 3V2
Withdrawn
28
Groupe Hospitalier Pitie-Salpetriere
Paris, France, 75013
Withdrawn
29
CHU Strasbourg - Hôpital Hautepierre
Strasbourg, France, 67200
Actively Recruiting
30
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany, 72076
Active, Not Recruiting
31
Vivantes Klinikum Neukoelln
Berlin, Germany, 12351
Actively Recruiting
32
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, Siena, Italy, 53100
Actively Recruiting
33
Azienda Ospedaliera Universitaria di Trieste
Trieste, Trieste, Italy, 34125
Actively Recruiting
34
Ospedale San Raffaele
Milan, Italy, 20123
Actively Recruiting
35
Università Campus Bio-Medico di Roma
Roma, Italy, 00128
Actively Recruiting
36
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
Verona, Italy, 37134
Actively Recruiting
37
BHI of Omsk region "Clinical Oncology Dispensary"
Omsk, Russia, 644013
Suspended
38
FSBI "National medical scientific center of psychiatry and neurology n.a. V.M. Bekhterev" Adolescent
Saint Petersburg, Russia, 192019
Suspended
39
FSBI North-West Federal Medical Research Center n.a. V.A. Almazov of MoH RF
Saint Petersburg, Russia, 197341
Suspended
40
LLC Medical Center Mart
Saint Petersburg, Russia, 199178
Suspended
41
RSBIH "Smolensk Regional Clinical Hospital"
Smolensk, Russia, 214019
Suspended
42
Federal State Budgetary Scientific Institution "Tomsk National Research Medical Centre of the Russia
Tomsk, Russia, 634009
Suspended
43
SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
Ufa, Russia, 450054
Suspended
44
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, South Korea, 24253
Withdrawn
45
Chonnam National University Hospital
Gwangju, Gyeonggi-do, South Korea, 61469
Withdrawn
46
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
47
Inje University Busan Paik Hospital
Busan, South Korea, 47392
Actively Recruiting
48
Pusan National University Hospital
Busan, South Korea, 49241
Actively Recruiting
49
Chosun University Hospital
Gwangju, South Korea, 61453
Actively Recruiting
50
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea, 06273
Actively Recruiting
51
Chung-Ang University Hospital
Seoul, South Korea, 06973
Actively Recruiting
Research Team
N
Nathalie LE FUR, PhD
CONTACT
F
Frantz HEBERT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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