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OpenTrials
Completed

NCT Number: NCT02291822

Retrospective Study of MRI in Pediatric Patients

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.

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Key information

Conditions

Central Nervous System Disease Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gadobenate dimeglumine

Drug

gadolinium contrast agent

Other names: MultiHance

Primary outcomes

  1. Border delineation of lesions

    Time frame: Immediately post dose - Day 1

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

  2. Visualization of internal morphology of lesions

    Time frame: 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)

  3. Contrast enhancement of lesions

    Time frame: Immediately post dose- Day 1

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

Sponsors and collaborators

Lead sponsor

Bracco Diagnostics, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 17, 2014
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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