Intra-individual Open-label, Single Center Study to Compare Unenhanced MRI With Dotarem Enhanced MRI in Pediatric and Neonatal Patient Population (<18years)

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

The goal of this study is to evaluate safety and efficacy of Dotarem enhanced MRI in pediatric and neonatal population who are referred for contrast enhanced MRI at Phoenix Children's Hospital.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: No
View:

• Any patient under 18 years of age who is scheduled for contrast enhanced MRI examination as part of their standard of care.

• Patients who are willing to undergo contrast enhanced MRI procedure

• Patients who are willing to comply with the study procedures (e.g. being followed-up for 24 hours after MRI procedure).

• Patients who have given their fully informed and written consent voluntarily.

Locations
United States
Arizona
Phoenix Children's Hospital
Phoenix
Time Frame
Start Date: February 9, 2017
Completion Date: November 12, 2017
Participants
Target number of participants: 250
Treatments
Dotarem Enhanced MRI
All pediatric patients (< 18 years) scheduled for clinically indicated contrast enhanced MRI (Brain MRI with/without contrast) will receive a single IV bolus injection of Dotarem at a dose of 0.1 mmol/kg bw at a flow rate of 1-2 mL/sec followed by saline flush (routine/ standard of care).
Authors
Jeffrey H Miller
Sponsors
Leads: Phoenix Children's Hospital
Collaborators: Guerbet

This content was sourced from clinicaltrials.gov

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