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

Study acronym: ODYSSEY
StatusRecruiting
PhasePhase 4
SponsorGuerbet
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Study sites: 47 to 51v10
  2. Minor Study sites: 43 to 47v9
  3. Minor Study sites: 32 to 43v8
  4. Minor Study sites: 15 to 32v7
  5. Minor Study sites: 6 to 15v6
Show 4 earlier versionsHide 4 earlier versions
  1. Minor Study sites: 1 to 6v5
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 31, 2021 to Mar 24, 2021
    v4
  3. Notable Start date: Jan 2021 to Mar 31, 2021
    • Primary and study completion dates: Jul 1, 2029 to Dec 31, 2028
    v3
  4. Notable Start date: Jul 1, 2020 to Jan 2021
    • Collaborators: 4 to 3
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
4 trials monitored
See all monitored trials
5,471 trials monitored
See 309 trials at risk
3,411 trials monitored
See 163 trials at risk
2,559 trials monitored
See 167 trials at risk
and 1 more disease
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.
Trial Details
NCT Number NCT04373564
Lead Sponsor Guerbet
Collaborators: Bayer AG (Sponsor), Bracco (Sponsor), GEHC (Sponsor)
Conditions
(from sponsor)
Motor Function, Cognitive Function, Contrast Media
Related terms Breast Neoplasms, Carcinoma, Hepatocellular, Colorectal Neoplasms, Neuroendocrine Tumors, Prostatic Neoplasms
Enrollment 2,076 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov