21181 Efficacy and safety of gadoquatrane for CNS MRI
Research type
Research Study
Full title
A multicenter, randomized, prospective double-blind, cross over Phase 3 study to evaluate the efficacy and safety of 0.04 mmol Gd/kg body weight of gadoquatrane for MRI in adults with known or suspected pathology of the central nervous system (CNS), compared to 0.1 mmol Gd/kg approved macrocyclic gadolinium-based contrast agents (GBCAs)
IRAS ID
1007413
Contact name
Maria Mac
Contact email
Sponsor organisation
Bayer AG
Eudract number
2022-501884-41
Research summary
Researchers are looking for a better way to help people with any known or suspected brain or spinal cord-related problems scheduled for a “contrast-enhanced” Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient’s vein to perform a “contrast-enhanced” MRI (CE-MRI). Such CE-MRI may help identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a “rare earth” element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work as well as those with currently used GBCAs. The researchers will compare the ability to detect brain and spinal cord-related problems in gadoquatrane-MRI scans to currently used GBCA-MRI scans.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
• take blood and urine samples
• do physical examinations
• check blood pressure and heart rate
• review the MRI scans obtained in the study and decide on the diagnosis
• ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
23/NE/0100
Date of REC Opinion
25 Aug 2023
REC opinion
Further Information Favourable Opinion