LEADER 75
Research type
Research Study
Full title
LowEr Administered Dose with highEr Relaxivity: Gadovist vs Dotarem
IRAS ID
254204
Contact name
Sachin Srivastava
Contact email
Sponsor organisation
Bayer AG
Eudract number
2018-000690-78
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
0 years, 8 months, 4 days
Research summary
This study is a Phase 4, multicenter, controlled, cross-over study with corresponding blinded image evaluations in male and female patients at least 18 years of age, who are referred for a contrast-enhanced MRI of the central nervous system (CNS) based on a known or highly suspected lesion of the CNS.
Magnetic Resonance scanners are machines capable of visualising the anatomy of the body and are used to diagnose medical conditions. Some medical conditions can be identified more easily if a diagnostic medicine is injected.
These diagnostic medicines are called Magnetic Resonance (MR) contrast agents. The MR images (MRI) obtained using MR contrast agents are referred to as “enhanced” or “contrast-enhanced”; MR images obtained without using MR contrast agents are referred to as “unenhanced”. MR contrast agents contain an element called gadolinium (Gd). Gadobutrol and gadoterate are two widely used gadolinium-based contrast agents.
The purpose of this study is to examine if contrast enhanced MRI acquired using a reduced dose of the gadolinium-based contrast agent gadobutrol are as good as images acquired using a full dose of the gadolinium-based contrast agent gadoterate.
Approximately 180 study participants will take part in the study in multiple countries. The study involves 2 scheduled visits to the hospital and it is expected that participants will take part in the study for no more than 20 days.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
18/YH/0466
Date of REC Opinion
13 Jun 2019
REC opinion
Further Information Favourable Opinion