NCT03147989

Retrospective Study of MRI With MULTIHANCE at 0.10 and 0.05 mmol/Kg Dose in CNS Patients

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 352 (actual)
• Sponsor: Bracco Diagnostics, Inc · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Central Nervous System Diseases
• Central Nervous System Neoplasms

Interventions

Type	Name	Description
DRUG	MultiHance	gadolinium contrast agent

Timeline

• Start date: 2017-05-18
• Primary completion: 2017-12-07
• Completion: 2018-03-16
• First posted: 2017-05-10
• Last updated: 2018-07-18

Locations

1 site across 1 country: United States