Central Nervous System Diseases Clinical Trial
Official title:
The Safety and Efficacy of ProHance® at the Dose of 0.10 mmol/kg in Magnetic Resonance Imaging of the Central Nervous System in Pediatric Patients Who Are Younger Than 2 Years of Age
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 routine clinical practice. Retrospective enrolment with a prospective blinded read.
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 collect MR images for a prospective blinded read to evaluate the efficacy of
PROHANCE in terms of visualization and enhancing properties.
The study will be conducted in 4-8 sites in the United States and Europe. It is estimated
that 120 patients will be enrolled to provide 108 evaluable patients.
Three radiologists unaffiliated with enrolling centers (blinded readers), blinded to the
patient's identity and clinical profile will independently evaluate the MRI images. The
efficacy analysis will be primarily based on the blinded reader evaluations.
Imaging conditions will represent those in routine clinical practice, inclusive of pre and
post-contrast images.
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