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Researchers are evaluating the potential effects of repeated use of gadolinium-based contrast agents (GBCAs) on motor and cognitive functions in neurologically normal adults over a period of five years. This Phase 4 study involves adults up to 65 years old who are likely to need at least yearly MRI or other imaging scans. The goal is to compare changes in body movement and mental skills between participants exposed to GBCAs multiple times and a matched group not exposed to GBCAs. Participants will undergo annual motor and cognitive tests to assess their functions. Unenhanced MRI scans of the brain will be performed at the start and after five years to check for abnormalities. Blood and urine samples will be collected yearly to measure gadolinium levels. The GBCAs administered during clinical care include various agents such as Gadoxetate disodium, Gadobenate dimeglumine, Gadodiamide, Gadoterate meglumine, Gadobutrol, and Gadoteridol. The study itself does not assign or control GBCA use; this is based on the participants' medical needs. Over the five-year study, participants will visit the study doctor at least seven times for physical exams, lab tests, and motor and cognitive assessments. Imaging tests like MRI, CT scans, or x-rays will be conducted annually. Researchers will measure changes in motor and cognitive performance compared to baseline and between GBCA-exposed and non-exposed groups. Safety and adverse events will also be monitored throughout the study period.

Age: 18Years - 64YearsAll GendersPhase 4
51 locations
Gwangju Si Clinical Trials | DecenTrialz