Central Nervous System Diseases Clinical Trial
Official title:
A Parallel-Group Comparison of Two Doses Of Multihance (0.10 mmol/Kg and 0.05 mmol/Kg) When Used For Magnetic Resonance Imaging (MRI) of The Central Nervous System (CNS)
This is a retrospective study to collect already existing data and images from patients ≥ 2 years of age who had MRI for CNS diseases with MultiHance administration at a standard 0.10 mmol/kg dose or the half dose of 0.05 mmol/kg. The MRI images of all included patients will be prospectively reviewed in a blinded read to compare the efficacy of the two doses.
This study is retrospective in design in that the MR images and other patient data, such as
demographic data, will be collected from existing data for the selected patients meeting the
inclusion criteria defined in this protocol. The study will be a multicenter study comparing
interindividually two groups, one group of patients having received MULTIHANCE at a standard
dose of 0.10 mmol/kg and the other group a dose of 0.05 mmol/kg for their clinically
indicated MRI examination.
In order to minimize selection bias, recruitment will start with the "Final Date" of this
protocol and, working backward chronologically from all the MR examinations stored in the
local site Picture Archiving and Communication Systems (PACS), every patient meeting the
inclusion criteria will be recruited for the study until the total number of patients (160)
in each group will be reached.
The images of all included patients will be prospectively reviewed in a blinded read.
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