NCT01211873

Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions

Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 416 (actual)
• Sponsor: Guerbet · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.

Detailed description

This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Dotarem®. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Dotarem® when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Dotarem®.

Conditions

• Diagnostic Self Evaluation
• Central Nervous System Diseases

Interventions

Type	Name	Description
DRUG	Dotarem (gadoterate meglumine)	0.1 mmol/kg by body weight, single IV injection
DRUG	Magnevist (gadopentetate dimeglumine)	0.1 mmol/kg by body weight, single IV injection

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-09-30
• Last updated: 2019-04-18
• Results posted: 2014-05-29

Locations

52 sites across 11 countries: United States, Argentina, Austria, Brazil, Chile, France, Germany, Italy, South Korea, Spain, United Kingdom