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

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.

Study Overview

• Status: Completed
• Conditions: Central Nervous System Diseases; Central Nervous System Neoplasms
• Intervention / Treatment: Drug: ProHance

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.

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will include patients younger than 2 years of age who have previously undergone MRI of the CNS (brain or spine) with PROHANCE at the dose of 0.1 mmol/kg as part of their clinical work-up.

Description

Inclusion Criteria:

• 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 Criteria:

• Exclude a patient from this study if the patient does not fulfill all of the inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Border delineation of lesions	Blinded reader will assess the border delineation of lesion based on a 5 point scale, none (0) - Excellent (4)	Immediately post dose - Day 1
Visualization of internal morphology of lesions	Blinded reader will assess the visualization of internal morphology of the lesion(s) based on a 5 point scale, none (0) - Excellent (4)	Immediately post dose - Day 1
Contrast enhancement of lesions	Blinded reader will assess the contrast enhancement of the lesion(s) based on a 5 point scale, none (0) - Excellent (4)	Immediately post dose- Day 1
Number and percentage of subjects with ProHance Related Adverse Events	In terms of frequency, type and severity of adverse events Data collected, will consist of Screening Serum Creatinine value (mg/dL), If available, Vital signs (systolic blood pressure, diastolic blood pressure, heart rate, respiration rate) and ECG.	up to 2 hours post-dose

Collaborators and Investigators

• Sponsor: Bracco Diagnostics, Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): September 17, 2019
• Study Completion (Actual): October 16, 2019

Study Registration Dates

• First Submitted: November 7, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: MRI; CNS; ProHance; Gadoteridol
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Nervous System Diseases; Nervous System Neoplasms; Central Nervous System Neoplasms; Central Nervous System Diseases
• Other Study ID Numbers: PH-108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No