Effects of Repeated Administration of Gadolinium-Based Contrast Media on Mobility and Cognitive Function

Magnetic resonance imaging (MRI) is an imaging technique that does not use X-rays and provides detailed images of the body’s interior. To better visualize certain structures, a contrast agent is administered through a vein (intravenously) before the exam. Gadolinium-based contrast agents contain the metal gadolinium, which may remain in the body in small amounts after administration. It is not yet conclusively clear whether these deposits have long-term health effects.

The goal of this Phase 4 study is to investigate, over a period of five years, whether repeated administration of contrast agents affects patients’ motor or cognitive abilities. Two types of gadolinium-based contrast agents will be compared: linear contrast agents, in which gadolinium is bound in a chain-like structure, and macrocyclic contrast agents, in which gadolinium is enclosed in a ring-like structure and is therefore considered more stable. Patients are not randomly assigned but are placed in one of three study arms based on the contrast agent already used in their clinical care: a study arm with linear contrast agents, a study arm with macrocyclic contrast agents, or a control arm without contrast agent administration. Patients in the control arm must not have previously received any gadolinium-based contrast agent. Throughout the study period, an MRI scan or other imaging tests (such as CT or X-ray) will be performed annually. In addition, assessments of motor function and cognitive performance will be conducted, along with blood and urine tests to measure gadolinium levels in the body. At the beginning and end of the study, all patients will undergo an MRI scan of the brain without contrast agent.

Eligible participants are patients between the ages of 18 and 64 who require imaging at least once a year due to an existing medical condition. These include, among others, breast cancer screening, prostate monitoring, chronic liver diseases, colorectal tumors, neuroendocrine tumors, and pancreatic cysts. Another requirement is that participants have no neurological or psychiatric conditions that could influence the test results.