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Safety and Efficacy Evaluatio...

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

Last Updated: 2019-04-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

416 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-11-30

Brief Summary

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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.

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Detailed Description

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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

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Diagnostic Self Evaluation Central Nervous System Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dotarem (gadoterate meglumine )

Dotarem and Magnevist were randomised as 2:1 ratio for adult patients.

Group Type EXPERIMENTAL