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 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 wi

Trial Details

NCT ID
NCT04373564
Phase
PHASE4
Sponsor
Guerbet
Status
RECRUITING
Cancer Type
Hepatocellular Carcinoma (HCC) Liver Cancer
Interventions
  • Motor Tests
  • Cognitive Tests
  • Unenhanced-MRI of the brain
  • Gadolinium Measurements
  • Gadoxetate disodium
  • Gadobenate dimeglumine
Locations (sample)
  • Scottsdale, Arizona, United States|33.50921,-111.89903
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Peoria, Illinois, United States|40.69365,-89.58899
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Participant must be neurologically normal, defined as free of unstable neurologic and psychiatric disease as confirmed by a normal neurologic exami…
  • Participant (GBCA-exposed or controls) agrees to undergo unenhanced magnetic resonance imaging (UE-MRI) of the brain at enrollment and at the end o…
  • Participants should have at least 1 of the following indications: a) Medium to high risk for breast cancer or dense breasts undergoing breast cance…
  • In addition, for participants in the GBCA Arms only:

For full eligibility, visit ClinicalTrials.gov.

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