Status:
COMPLETED
Evaluation of Safety and Efficacy of ProHance in Pediatric Patients <2yrs
Lead Sponsor:
Bracco Diagnostics, Inc
Conditions:
Central Nervous System Diseases
Central Nervous System Neoplasms
Eligibility:
All Genders
1-2 years
Brief Summary
Safety and Efficacy Study in pediatric subjects \<2 years of age who have undergone Brain or Spine MRI pre and post 0.1 mmol/kg ProHance administration. Imaging conditions will represent those in rout...
Detailed Description
The purpose of this study is to retrospectively enroll children younger than 2 years of age who have undergone brain or spine MRI with 0.1 mmol/kg PROHANCE and to gather safety data as well as to coll...
Eligibility Criteria
Inclusion
- Is male or female and was younger than 2 years of age at the time of the MRI with PROHANCE injection at the dose of 0.1 mmol/kg (±25% in volume administered).
- Has demographic information, reason for the ProHance-enhanced MR examination, relevant medical history, final diagnosis, and safety data available.
- Has documented known or highly suspected enhancing disease of CNS (brain/spine) and previously underwent a cranial or spinal MR examination requiring an injection of PROHANCE contrast agent.
- Has both predose and postdose T1 SE/FSE and/or GRE and T2 SE/FSE, and FLAIR MR images (when available) for submission to Bracco or designee to be evaluated in a fully blinded read.
- Has complete information on the imaging protocol used for the ProHance-enhanced MR exam including type of exam (brain or spine), MR scanner and field strength (1.0, 1.5 or 3.0 Tesla)
- Has a documented dose of PROHANCE administered for their MRI exam and/or the volume (mL) and weight of the patient available to be used to calculate the exact dose of PROHANCE that was administered.
Exclusion
- • Exclude a patient from this study if the patient does not fulfill all of the inclusion criteria.
Key Trial Info
Start Date :
November 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 16 2019
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT03750188
Start Date
November 1 2018
End Date
October 16 2019
Last Update
January 23 2020
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425