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NCT04373564 · ClinicalTrials.gov registry record · 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

A Phase 4 study of Cognitive Function and Motor Function, sponsored by Guerbet.

Recruiting
Registry status
Phase 4
Development phase
2,076
Enrollment target
20
Study locations

NCT04373564 is a Phase 4 study of Cognitive Function and Motor Function that is actively recruiting participants, run by Guerbet. The registered enrollment target is 2,076 participants, above the 394-participant average among 20 other Cognitive Function trials with a reported enrollment target (427% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT04373564, a Phase 4 study of Cognitive Function and Motor Function, is actively recruiting participants, sponsored by Guerbet.

RECRUITING
Registry status
Phase 4
Development phase
2,076 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Cognitive Function Motor Function Contrast Media

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

15 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, categorized as Phase 4. The registered enrollment target is 2,076 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 394-participant average among 20 other Cognitive Function trials with a reported enrollment target (427% higher). The listed sponsor is Guerbet, which has 15 total studies on file at ClinicalTrials.gov.

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.

NCT04373564 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Massachusetts, Illinois, Pennsylvania.

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.

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).

Who is sponsoring clinical trial NCT04373564?

This trial is sponsored by Guerbet, which has 15 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.