Retrospective Study of MRI in Pediatric Patients

Central Nervous System Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291822
• Other study ID #: MH-150
• Status: Completed
• Phase: N/A
• First received: November 6, 2014
• Last updated: July 18, 2016
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Central Nervous System Disease
• Central Nervous System Diseases
• Central Nervous System Neoplasms
• Nervous System Diseases
• Nervous System Neoplasms

Intervention

Drug:
• Gadobenate Dimeglumine
gadolinium contrast agent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Border delineation of lesions	Unenhanced MRI and contrast enhanced MRI are superior to unenhanced MRI alone in terms of lesion border delineation	Immediately post dose - Day 1	No
Primary	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)	Immediately post dose - Day 1	No
Primary	Contrast enhancement of lesions	Unenhanced MRI and contrast enhanced MRI are superior to unenhanced MRI alone in terms of contrast enhancement of lesions	Immediately post dose- Day 1	No