Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
Public ClinicalTrials.gov record NCT04373564. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04373564
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 2,076 participants
Conditions and interventions
Conditions
Interventions
- Motor Tests Procedure
- Cognitive Tests Procedure
- Unenhanced-MRI of the brain Procedure
- Gadolinium Measurements Procedure
- Gadoxetate disodium Drug
- Gadobenate dimeglumine Drug
- Gadodiamide Drug
- Gadoterate meglumine Drug
- Gadobutrol Drug
- Gadoteridol Drug
Procedure · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 23, 2021
- Primary completion
- Dec 30, 2028
- Completion
- Dec 30, 2028
- Last update posted
- Jan 21, 2026
2021 – 2028
United States locations
- U.S. sites
- 16
- U.S. states
- 9
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Scottsdale Medical Imaging, LLC | Scottsdale | Arizona | 85260 | Recruiting |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | Withdrawn |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | Recruiting |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61637 | Recruiting |
| Massachussets General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Boston University Medical Center | Boston | Massachusetts | 02118 | Terminated |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Withdrawn |
| ActivMed Practices & Research, Inc. | Methuen | Massachusetts | 01844 | Withdrawn |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | Terminated |
| Department of Radiology | St Louis | Missouri | 63110 | Withdrawn |
| UNC School of Medicine | Chapel Hill | North Carolina | 27599 | Withdrawn |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | Recruiting |
| Albert Einstein Healthcare Network | Philadelphia | Pennsylvania | 19141 | Recruiting |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | 77030 | Withdrawn |
| University of Wisconsin | Madison | Wisconsin | 53792 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 35 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04373564, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 21, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04373564 live on ClinicalTrials.gov.