NCT03602339

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Magnetic Resonance Imaging

Interventions

Type	Name	Description
DRUG	Gadoterate (Dotarem/Clariscan)	Patients received a single dose of 0.5 molar gadoterate (0.1 mmol per kg body weight) intravenously.
DRUG	Gadobutrol (Gadavist/Gadovist, BAY86-4875)	Patients received a single dose of 1.0 molar BAY86-4875 (0.075 mmol per kg body weight) intravenously.

Timeline

• Start date: 2018-11-14
• Primary completion: 2020-03-13
• Completion: 2020-05-26
• First posted: 2018-07-26
• Last updated: 2021-06-14
• Results posted: 2021-04-28

Locations

20 sites across 7 countries: United States, France, Germany, Italy, South Korea, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study