NCT04373564

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

Prospective Evaluation of Potential Effects of Repeated Gadolinium-based Contrast Agent (GBCA) Administrations of the Same GBCA on Motor and Cognitive Functions in Neurologically Normal Adults in Comparison to a Non-GBCA Exposed Control Group

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,076 (estimated)
• Sponsor: Guerbet · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The primary objective of the study is to assess the potential effect of repeated exposure to either a linear or a macrocyclic gadolinium-based contrast agent (GBCA) on change from baseline to Year 5 in composite measure of motor and cognitive function among neurologically normal adults in comparison to a matched non-GBCA- exposed control group. The secondary objectives comprise the assessment of the following endpoints in GBCA-exposed participants as compared to controls a) changes from baseline in composite measure of motor and cognitive function post-baseline on yearly basis (Years 1 to 4); b) changes from baseline in each individual test of motor and cognitive function on yearly basis (Years 1 to 5). Total Gd concentrations in blood and urine samples on yearly basis (Years 1 to 5) and adverse events will be collected as secondary objectives. Of note : The study is considered interventional because of the addition of UE-MRI scans for all participants, as well as blood sampling and the administration of the motor and cognitive tests. The GBCA administered as part of the contrast-enhanced MR imaging in the experimental arms is not the intervention in this study. Neither the protocol nor the investigators assign patients to a specific GBCA as part of the study, making this part of the study observational rather than interventional. The participants were already scheduled, prior to study screening, to undergo CE-MRI as part of their clinical care. The choice of GBCA for the CE-MRI will be based on medical need and institutional usage of GBCA, independent of study participation.

Conditions

• Motor Function
• Cognitive Function
• Contrast Media

Interventions

Type	Name	Description
PROCEDURE	Motor Tests	To assess motor function annually
PROCEDURE	Cognitive Tests	To assess cognitive function annually
PROCEDURE	Unenhanced-MRI of the brain	The UE-MRI of the brain will be performed at baseline and at the year 5 visit in order to exclude presence of a significant MRI abnormality
PROCEDURE	Gadolinium Measurements	Blood samples and spontaneous urine specimens will be collected through the course of the study to measure Gd concentration
DRUG	Gadoxetate disodium	Administered as defined by the treating physician as part of routine clinical practice
DRUG	Gadobenate dimeglumine	Administered as defined by the treating physician as part of routine clinical practice
DRUG	Gadodiamide	Administered as defined by the treating physician as part of routine clinical practice
DRUG	Gadoterate meglumine	Administered as defined by the treating physician as part of routine clinical practice
DRUG	Gadobutrol	Administered as defined by the treating physician as part of routine clinical practice
DRUG	Gadoteridol	Administered as defined by the treating physician as part of routine clinical practice

Timeline

• Start date: 2021-03-24
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2020-05-04
• Last updated: 2026-01-22

Locations

51 sites across 8 countries: United States, Brazil, Canada, France, Germany, Italy, Russia, South Korea

Regulatory

• FDA-regulated drug study