Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
Recruiting
Phase 4
Interventional Study
Motor Function
Cognitive Function
Contrast Media
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 64
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 2,076 (estimated)
- Sponsor
- Guerbet · Industry
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About This Trial
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 mout…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participant must be neurologically normal, defined as free of unstable neurologic and psychiatric disease as confirmed by a normal neurologic examination at screening
* Participant (GBCA-exposed or controls) agrees to undergo unenhanced magnetic resonance imaging (UE-MRI) of t…
Contacts