Conditions: Diagnostic Self Evaluation Central Nervous System Diseases
Keywords: CNS Contrast Agent MRI Dotarem Magnevist
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 416
Healthy volunteers: no

Brief 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®.

Arms:
arm 1: Dotarem and Magnevist were randomised as 2:1 ratio for adult patients. arm 2: Dotarem and Magnevist were randomised as 2:1 ratio arm 3: Pediatric patients were assigned to Dotarem group only.

Interventions: intervention 1: Dotarem (gadoterate meglumine) intervention 2: Magnevist (gadopentetate dimeglumine)
Intervention descriptions: intervention 1: 0.1 mmol/kg by body weight, single IV injection intervention 2: 0.1 mmol/kg by body weight, single IV injection

Protocol document: