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

NCT03750188 | Completed FDA Drug

• 1 other identifier: PH-108
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Nervous System Diseases; Central Nervous System Neoplasms

Keywords

CNS; MRI; ProHance; Gadoteridol

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

ProHance DRUG

0.1 mmol/kg ProHance intravenous injection

Also known as: Gadoteridol

Eligibility Criteria

• Age: 1 Day - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Central Nervous System Diseases; Central Nervous System Neoplasms

Interventions

gadoteridol

Condition Hierarchy (Ancestors)

Nervous System Diseases; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Gianpaolo Pirovano, MD

  Bracco Diagnostics, Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 21, 2018
• Study Start: November 1, 2018
• Primary Completion: September 17, 2019
• Study Completion: October 16, 2019
• Last Updated: January 23, 2020

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)