RecruitingPhase 4NCT04373564

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

Sponsor

Guerbet

Enrollment

2,076 participants

Start Date

Mar 24, 2021

Study Type

INTERVENTIONAL

Conditions

Cognitive Function Motor Function Contrast Media

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.

Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether repeated exposure to gadolinium-based contrast dye (used in certain MRI scans) causes any changes in movement or thinking skills over 5 years. You may be eligible if... - You have a neurologically normal health status with no unstable neurological or psychiatric conditions - You are undergoing regular MRI scans for conditions like breast cancer screening, prostate monitoring, liver disease surveillance, or certain pancreatic or colorectal monitoring - You are expected to have at least 5 contrast MRI scans over the study period (for the contrast group), OR you have never had contrast dye and won't during the study (for the control group) You may NOT be eligible if... - You have any neurological or psychiatric conditions that could affect the motor or thinking tests - You are on medications that affect your brain or movement - You have kidney disease (eGFR below 60) - You are pregnant or breastfeeding - You have certain metal implants incompatible with MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREMotor Tests

To assess motor function annually

PROCEDURECognitive Tests

To assess cognitive function annually

PROCEDUREUnenhanced-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

PROCEDUREGadolinium Measurements

Blood samples and spontaneous urine specimens will be collected through the course of the study to measure Gd concentration

DRUGGadoxetate disodium