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

Conditions

• Cognitive Function
• Contrast Media
• Motor Function

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Not accepted

Interventions

• Motor Tests — PROCEDURE
  To assess motor function annually
• Cognitive Tests — PROCEDURE
  To assess cognitive function annually
• Unenhanced-MRI of the brain — PROCEDURE
  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
• Gadolinium Measurements — PROCEDURE
  Blood samples and spontaneous urine specimens will be collected through the course of the study to measure Gd concentration
• Gadoxetate disodium — DRUG
  Administered as defined by the treating physician as part of routine clinical practice
• Gadobenate dimeglumine — DRUG
  Administered as defined by the treating physician as part of routine clinical practice
• Gadodiamide — DRUG
  Administered as defined by the treating physician as part of routine clinical practice
• Gadoterate meglumine — DRUG
  Administered as defined by the treating physician as part of routine clinical practice
• Gadobutrol — DRUG
  Administered as defined by the treating physician as part of routine clinical practice
• Gadoteridol — DRUG
  Administered as defined by the treating physician as part of routine clinical practice

Study Details

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.

Key Dates

Start date

Mar 24, 2021

Status verified

Jan 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

2,076 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: Linear GBCAs
  Adult participants, who were scheduled for repeated enhanced magnetic resonance imaging (MRI), receive a linear gadoliniumbased contrast agent (GBCA, i.e. Eovist/ Primovist, MultiHance or Omniscan) prior to MRI. Each participant will receive the same GBCA throughout the study.
• Experimental: Macrocyclic GBCAs
  Adult participants, who were scheduled for repeated enhanced magnetic resonance imaging (MRI), receive a macrocyclic gadolinium-based contrast agent (GBCA, i.e. Gadavist/ Gadovist, Dotarem, Magnescope or ProHance) prior to MRI. Each participant will receive the same GBCA throughout the study.
• Other: No GBCA (Control arm)
  Adult participants who were never exposed to any gadolinium-based contrast agent and matching the population characteristics of the two GBCA arms. They will not receive any gadolinium-based contrast agent over the study course, but may undergo clinically indicated imaging (e.g. unenhanced magnetic resonance imaging (MRI), unenhanced or enhanced computed tomography, ultrasound and/or X-ray).

Primary Outcome Measure

Change of motor function from baseline to year 5 in comparison to a matched non-GBCA-exposed control group [ Time Frame: At baseline, year 5 ]

Central Contacts

• Nathalie LE FUR, PhD
  +33649351166
  [email protected]
• Frantz HEBERT
  +33680249334
  [email protected]

Locations (16)

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