Retrospective Study of MRI in Pediatric Patients

The Safety and Efficacy of MULTIHANCE at the Dose of 0.10 mmol/kg in Magnetic Resonance Imaging of the Central Nervous System in Pediatric Patients Who Are Less Than 2 Years of Age

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02291822

Enrollment

Registered

2014-11-17

Start date

2014-11-30

Completion date

2015-12-31

Last updated

2016-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System Disease, Central Nervous System Neoplasms

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 designed blinded reading of the images.

Interventions

DRUGGadobenate Dimeglumine

gadolinium contrast agent

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 2 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Border delineation of lesions	Immediately post dose - Day 1	Unenhanced MRI and contrast enhanced MRI are superior to unenhanced MRI alone in terms of lesion border delineation
Visualization of internal morphology of lesions	Immediately post dose - Day 1	Unenhanced MRI and contrast enhanced MRI are superior to unenhanced MRI alone in terms of visualization of internal morphology of the lesion(s)
Contrast enhancement of lesions	Immediately post dose- Day 1	Unenhanced MRI and contrast enhanced MRI are superior to unenhanced MRI alone in terms of contrast enhancement of lesions

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026