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RECRUITING Phase 4

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

NCT04373564 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • PROCEDURE Motor Tests
  • PROCEDURE Cognitive Tests
  • PROCEDURE Unenhanced-MRI of the brain
  • PROCEDURE Gadolinium Measurements
  • DRUG Gadoxetate disodium

Study Locations (20)

Massachusetts

  • Massachussets General Hospital — Boston
  • Boston University Medical Center — Boston
  • Beth Israel Deaconess Medical Center — Boston
  • ActivMed Practices & Research, Inc. — Methuen
  • University of Massachusetts Memorial Medical Center — Worcester

Illinois

  • University of Chicago Medical Center — Chicago
  • Methodist Medical Center of Illinois — Peoria

Pennsylvania

  • Penn State Hershey Medical Center — Hershey
  • Albert Einstein Healthcare Network — Philadelphia

Texas

  • UT Southwestern Medical Center — Dallas
  • MD Anderson Cancer Center — Houston

Rio Grande do Sul

  • Instituto Mederi de Pesquisa e Saude — Passo Fundo
  • Hospital Moinhos de Vento — Porto Alegre

Arizona

  • Scottsdale Medical Imaging, LLC — Scottsdale

Connecticut

  • Yale University School of Medicine — New Haven

Missouri

  • Department of Radiology — St Louis

Trial Details

FieldValue
Enrollment Target 2,076 participants
Start Date 2021-03-24
Est. Completion 2028-12-31
Phase Phase 4

Sponsor

Guerbet

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04373564

The ClinicalTrials.gov registry entry for NCT04373564 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,076 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Guerbet, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Cognitive Function appearing as the primary indexed condition, and to 5 interventions — of which Motor Tests is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04373564 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Massachusetts, Illinois, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04373564 about?

NCT04373564 is a clinical study titled "Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years". 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 contr...

What is the current status of trial NCT04373564?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 2,076 participants. The study started on 2021-03-24. Estimated completion is 2028-12-31.

What conditions does trial NCT04373564 study?

This clinical trial studies the following conditions: Cognitive Function, Motor Function, Contrast Media. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04373564?

The interventions under investigation include: Motor Tests (PROCEDURE), Cognitive Tests (PROCEDURE), Unenhanced-MRI of the brain (PROCEDURE), Gadolinium Measurements (PROCEDURE), Gadoxetate disodium (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04373564?

This trial is sponsored by Guerbet, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04373564 being conducted?

This trial has 20 study locations across Arizona, Connecticut, Illinois, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial