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Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose — LEADER 75  

Magnetic Resonance Imaging Clinical Trial

Official title:
LowEr Administered Dose With highEr Relaxivity: Gadovist vs Dotarem (LEADER 75)

Clinical Trial Summary

The study was conducted to gain knowledge about a new dose of a diagnostic drug that is used for contrast-enhanced Magnetic Resonance Imaging (MRI) of the human central nervous system (CNS). MRI can visualize the anatomy of the body and is used to detect medical conditions. Diagnostic drugs like gadobutrol and gadoterate contain an element called gadolinium that is applied to improve the analysability of MRI-images. The purpose of this study was to examine if contrast-enhanced MRI using a reduced dose of the gadolinium-based contrast agent gadobutrol delivers images of similar quality to those obtained when a full dose of the gadolinium-based contrast agent gadoterate was used.

Clinical Trial Description

The study was an open-label, multi-center, comparative, cross-over trial in adult patients with known or highly suspected CNS pathology who were referred for imaging of the CNS. The primary objective of the study was to demonstrate the non-inferiority of gadobutrol (0.075 mmol/ kg body weight) to gadoterate (0.1 mmol/ kg body weight). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03602339
Study type Interventional
Source Bayer
Contact
Status Completed
Phase Phase 4
Start date November 14, 2018
Completion date May 26, 2020
View Details
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