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Retrospective Study of MRI in Pediatric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291822
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

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.

Condition or disease Intervention/treatment
Central Nervous System Disease Central Nervous System Neoplasms Drug: Gadobenate Dimeglumine

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official 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
Study Start Date : November 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Gadobenate Dimeglumine
    gadolinium contrast agent
    Other Name: MultiHance


Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients less than 2 years of age who have previously undergone a MRI of the brain or spine with MultiHance
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291822


Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
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Study Director: Gianpaolo Priovano, M.D. Bracco Diagnostics, Inc
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Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT02291822    
Other Study ID Numbers: MH-150
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: May 2015
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Nervous System Diseases
Central Nervous System Diseases
Neoplasms by Site
Neoplasms