Study on Effects of Repeated Gadolinium-Based Contrast Agents on Movement and Thinking Skills in Adults Aged 18 to 64 Undergoing MRI Scans

What this Trial Is About

Researchers are evaluating the potential effects of repeated use of gadolinium-based contrast agents GBCAs on body movement and mental skills in adults aged 18 to 65 who are neurologically normal. This study is a postmarketing requirement conducted by several pharmaceutical companies and a contract research organization. It aims to compare motor and cognitive functions over five years between participants exposed to GBCAs during their routine medical imaging and those who are not exposed to these contrast agents. Participants fall into three groups those receiving linear GBCAs, those receiving macrocyclic GBCAs, and a control group not exposed to any GBCAs. Each participant in the GBCA groups is scheduled for at least five enhanced MRI scans using the same agent annually over five years. The control group undergoes clinically indicated imaging without GBCA exposure. All participants will have motor and cognitive tests yearly, blood and urine samples collected for gadolinium levels, and unenhanced brain MRI scans at the start and end of the study. During the study, participants will visit their doctor at least seven times over five years for physical exams, laboratory tests, and assessments of motor and cognitive functions. Researchers will measure changes in motor and cognitive abilities from baseline to year five, along with yearly evaluations. Safety will be monitored through adverse event reporting and gadolinium concentration measurements. The total study duration for each participant is five years, including annual imaging and clinical assessments.

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