Retrospective Study of MRI in Pediatric Patients

• Sponsor: Bracco Diagnostics, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02291822
• Collaborator: (none)
• Enrollment: 90
• Duration (Months): 13

Study Details

Study Description

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	Phase
Central Nervous System Disease; Central Nervous System Neoplasms	Drug: Gadobenate Dimeglumine

Study Design

• 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: Nov 1, 2014
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Outcome Measures

Primary Outcome Measures

1. 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

2. 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)

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 2 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bracco Diagnostics, Inc

Investigators

• Study Director: Gianpaolo Priovano, M.D., Bracco Diagnostics, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bracco Diagnostics, Inc
• ClinicalTrials.gov Identifier: NCT02291822
• Other Study ID Numbers: MH-150
• First Posted: Nov 17, 2014
• Last Update Posted: Jul 19, 2016
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms; Nervous System Diseases; Central Nervous System Diseases

Study Results

No Results Posted as of Jul 19, 2016