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

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.

Conditions

• Motor Function
• Cognitive Function
• Contrast Media

Interventions

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

Sponsors & Collaborators

• Bayer AG (Sponsor)

  collaborator UNKNOWN

• Bracco (Sponsor)

  collaborator UNKNOWN

• GEHC (Sponsor)

  collaborator UNKNOWN

• Guerbet

  lead INDUSTRY

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-24

Primary Completion

2028-12-31

Completion

2028-12-31

FDA Drug

Yes

Countries

• United States
• Brazil
• Canada
• France
• Germany
• Italy
• Russia
• South Korea

Study Locations