Spots Global Cancer Trial Database for Evaluation of Safety and Efficacy of ProHance in Pediatric Patients <2yrs

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Trial Identification

Brief Title: Evaluation of Safety and Efficacy of ProHance in Pediatric Patients <2yrs

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

Study ID: NCT03750188

Conditions

Central Nervous System Diseases

Central Nervous System Neoplasms

Interventions

ProHance

Study Description

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 routine clinical practice. Retrospective enrolment with a prospective blinded read.

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 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.