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
Guerbet
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.
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);…
Eligibility
- Age range
- 18–64 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must be neurologically normal, defined as free of unstable neurologic and psychiatric disease as confirmed by a normal neurologic examination at screening * Participant (GBCA-exposed or controls) agrees to undergo unenhanced magnetic resonance imaging (UE-MRI) of the brain at enrollment and at the end of the observation period (5 years) * Participants should have at least 1 of the following indications: a) Medium to high risk for breast cancer or dense breasts undergoing breast cancer screening with MRI, b) Elevated prostate-specific antigen (PSA) and under a…
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
Administered as defined by the treating physician as part of routine clinical practice
- DrugGadobenate dimeglumine
Administered as defined by the treating physician as part of routine clinical practice
Locations (51)
- Scottsdale Medical Imaging, LLCScottsdale, Arizona
- Yale University School of MedicineNew Haven, Connecticut
- University of Chicago Medical CenterChicago, Illinois
- Methodist Medical Center of IllinoisPeoria, Illinois
- Massachussets General HospitalBoston, Massachusetts
- Boston University Medical CenterBoston, Massachusetts