Actively Recruiting
Evaluation of Effects of Repeated Gadolinium-based Contrast Agent Use on Motor and Cognitive Functions in Neurologically Normal Adults Compared to Non-Exposed Controls
Led by Guerbet · Updated on 2026-01-22
2076
Participants Needed
51
Research Sites
N/A
Total Duration
On this page
Sponsors
G
Guerbet
Lead Sponsor
B
Bayer AG (Sponsor)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the potential effects of repeated use of gadolinium-based contrast agents (GBCAs) on body movement and mental skills in adults aged 18 to 65 who are neurologically normal. This study is a postmarketing requirement conducted by several pharmaceutical companies and a contract research organization. It aims to compare motor and cognitive functions over five years between participants exposed to GBCAs during their routine medical imaging and those who are not exposed to these contrast agents. Participants fall into three groups: those receiving linear GBCAs, those receiving macrocyclic GBCAs, and a control group not exposed to any GBCAs. Each participant in the GBCA groups is scheduled for at least five enhanced MRI scans using the same agent annually over five years. The control group undergoes clinically indicated imaging without GBCA exposure. All participants will have motor and cognitive tests yearly, blood and urine samples collected for gadolinium levels, and unenhanced brain MRI scans at the start and end of the study. During the study, participants will visit their doctor at least seven times over five years for physical exams, laboratory tests, and assessments of motor and cognitive functions. Researchers will measure changes in motor and cognitive abilities from baseline to year five, along with yearly evaluations. Safety will be monitored through adverse event reporting and gadolinium concentration measurements. The total study duration for each participant is five years, including annual imaging and clinical assessments.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 64 years
- Neurologically normal with no unstable neurological or psychiatric diseases confirmed by screening exam
- Willing to undergo unenhanced MRI of the brain at enrollment and at 5 years
- Have at least one of these conditions: medium to high breast cancer risk or dense breasts with MRI screening, elevated PSA under prostate cancer surveillance, chronic liver disease under surveillance, low-grade colorectal or neuroendocrine tumors monitored for liver metastases, or small branch-duct IPMN of the pancreas under imaging surveillance
- For GBCA groups: scheduled for at least five GBCA-enhanced MRIs using the same GBCA annually over 5 years
- Up to three documented prior exposures to the same GBCA allowed
- For control group: no prior GBCA exposure and unlikely to receive GBCA during study
- Control participants must undergo unenhanced brain MRI at baseline and year 5; may have clinically indicated imaging 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, malignancies other than specified, epilepsy, prior neurosurgery, psychotic disorders, schizophrenia, major depressive or bipolar disorder with recent episodes, neurodevelopmental disorders, uncontrolled severe migraine, or recent anxiety or depression
- Prior, planned, or ongoing chemotherapy or brain irradiation
- Use of medications affecting neurocognitive 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 or pesticides
- Need for more than one contrast-enhanced MRI every 6 months
- Pregnant or nursing women
- Presence of any metal-containing joint implants or prostheses
- For GBCA groups: prior exposure to a different GBCA than the one used in study
- For control group: any prior GBCA exposure or contraindications to unenhanced brain MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo unenhanced MRI of the brain, motor and cognitive tests, and blood and urine sampling to measure gadolinium concentration at the start of the study.
1 baseline visit (in-person)
Duration - 5 years
Participants complete motor and cognitive tests and provide blood and urine samples yearly to monitor changes in motor and cognitive function and gadolinium levels.
Annual visits for up to 5 years (in-person)
Duration - 1 day
At the final year, participants undergo unenhanced MRI of the brain, motor and cognitive tests, and blood and urine sampling to assess long-term effects.
1 visit (in-person)
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
F
Frantz HEBERT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here