Retrospective Study of MRI in Pediatric Patients

Bracco Diagnostics, Inc90 enrolled

Overview

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 designed blinded reading of the images.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Central Nervous System Disease Central Nervous System Neoplasms

Interventions

Gadobenate DimeglumineDRUG

gadolinium contrast agent

Eligibility

Sex: ALLMax age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * Any patient who does not fulfill all of the inclusion criteria

Outcomes

Primary Outcomes

Border delineation of lesions

Unenhanced MRI and contrast enhanced MRI are superior to unenhanced MRI alone in terms of lesion border delineation

Time frame: Immediately post dose - Day 1

Visualization of internal morphology of lesions

Unenhanced MRI and contrast enhanced MRI are superior to unenhanced MRI alone in terms of visualization of internal morphology of the lesion(s)

Time frame: Immediately post dose - Day 1

Contrast enhancement of lesions

Unenhanced MRI and contrast enhanced MRI are superior to unenhanced MRI alone in terms of contrast enhancement of lesions

Time frame: Immediately post dose- Day 1

Data from ClinicalTrials.gov

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