account_circleRecruiting
Motor Function / Cognitive Function / Contrast Media
Bayer Identifier:
20405
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
Trial purpose
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.
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 Participants Requirements
Sex
AllAge
18 - 64 YearsTrial summary
Enrollment Goal
2076Trial Dates
March 2021 - December 2028Phase
Phase 4Could I Receive a placebo
NoProducts
Eovist/Primovist (Gadoxetate disodium, BAY86-4873)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Many Locations | Many Locations, 27599, United States |
Recruiting | Many Locations | Many Locations, Korea, Republic Of |
Recruiting | Many Locations | Many Locations, 02114-2696, United States |
Recruiting | Many Locations | Many Locations, 17033, United States |
Recruiting | Many Locations | Many Locations, 75390, United States |
Recruiting | Many Locations | Many Locations, 53792, United States |
Recruiting | Many Locations | Many Locations, 61637, United States |
Recruiting | Many Locations | Many Locations, 85260, United States |
Recruiting | Many Locations | Many Locations, Brazil |
Suspended | Many Locations | Many Locations, Russian Federation |
Recruiting | Many Locations | Many Locations, Italy |
Recruiting | Sao Jose Rio Preto, 15090-000, Brazil | |
Recruiting | Instituto Mederi de Pesquisa e Saude | Passo Fundo, 99010-120, Brazil |
Primary Outcome
- Change of motor function from baseline to year 5 in comparison to a matched non-GBCA-exposed control groupThe endpoint is a composite z score, defined as the weighted sum of the z scores of the individual tests.date_rangeTime Frame:At baseline, year 5
- Change in cognitive function from baseline to year 5 in comparison to a matched non-GBCA-exposed control groupThe endpoint is a composite z score, defined as the weighted sum of the z scores of the individual tests.date_rangeTime Frame:At baseline, year 5
Secondary Outcome
- Change from baseline in the composite endpoints (motor and cognitive) at each of the post-baseline time points (Years 1 to 4) in GBCA-exposed participants as compared to controlsThe endpoint is a composite z score, defined as the weighted sum of the z scores of the individual tests.date_rangeTime Frame:At baseline, years 1, 2, 3, 4
- Change from baseline for each of the individual tests (motor and cognitive) at each of the post-baseline time points (Years 1 to 5) in GBCA-exposed participants as compared to controlsThe endpoint is a composite z score, defined as the weighted sum of the z scores of the individual tests.date_rangeTime Frame:At baseline, years 1, 2, 3, 4
- Number of participants with adverse eventsdate_rangeTime Frame:At baseline, years 1, 2, 3, 4, 5
- Total Gd concentrations (as measured in a central laboratory) in blood and urine samples taken from exposed and control participants at the time of the annual visitdate_rangeTime Frame:At baseline, years 1, 2, 3, 4 and 5
Trial design
Trial Type
InterventionalIntervention Type
Procedure/SurgeryTrial Purpose
OtherAllocation
Non-randomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
3