Status:
COMPLETED
Retrospective Study of MRI in Pediatric Patients
Lead Sponsor:
Bracco Diagnostics, Inc
Conditions:
Central Nervous System Disease
Central Nervous System Neoplasms
Eligibility:
All Genders
Up to 2 years
Brief Summary
Collection of already existing data and images for patients \< 2 years of age having MultiHance administration for a MRI of the brain or spine. MR Images will be reviewed during a prospectively design...
Eligibility Criteria
Inclusion
- Male or female less than 2 years of age at the time of the MRI with MultiHance injection at a dose of 0.1 mmol/kg (± 25% in volume administered)
- Has available demographic and safety data
- Has documented known or highly suspected enhancing disease of the CNS (brain/spine) and previously underwent a cranial or spinal MR examination requiring an injection of MULTIHANCE contrast agent
- Has both pre and post dose T1 SE/FSE and/or GRE and T2 SE/FSE, and FLAIR MR images (when available) for submission to sponsor or designee to be evaluated in a fully blinded read
- Has a documented dose of MultiHance administered for their MRI exam and/or volume (mL) and weight of the patient available to be used to calculate the dose of MultiHance that was administered
Exclusion
- Any patient who does not fulfill all of the inclusion criteria
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT02291822
Start Date
November 1 2014
End Date
December 1 2015
Last Update
July 19 2016
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