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
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Locations near you
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Full eligibility criteria for NCT03023566
Ages eligible for Study
up to 18 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
Patients receiving an MRI exam without contrast.
Patients who are pregnant, lactating or who are > 11 years old and have not had a negative urine pregnancy test the same day as administration of Dotarem. The manufacturer's instructions for performing the urinary pregnancy test are to be followed.
Having an underlying disease or concomitant medication which may interfere with efficacy or safety evaluations as planned in this study.
Patients with a Glomerular Filtration Rate (GFR) < 30.
Having received any investigational drug within 30 days prior to entering this study or who are planned to receive any investigational drug during the 24 (+ / - 4) hour safety follow-up period.
Not being able to remain lying down for at least 45 - 60 min (e.g. patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain).
Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents .
Patients who have received any other contrast medium within 24 hours prior to Dotarem injection or are scheduled to receive any other contrast medium within the follow-up period.
Being clinically unstable and whose clinical course during the 24 (+ / - 4) hours observation period is unpredictable.
Being scheduled for, or likely to require, any surgical intervention within 24 hours before or within the follow-up period.
Having any contraindication to MRI examination (e.g. pacemaker, recent wound clips, and severe claustrophobia).
Having been previously enrolled in this study.
All locations for NCT03023566
United States (1)
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
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View full eligibility
Tris trial is registered with FDA with number: NCT03023566. The sponsor of the trial is Phoenix Children's Hospital and it is looking for 250 volunteers for the current phase.
Official trial title: Intra-individual Open-label, Single Center Study to Compare Unenhanced MRI With Dotarem Enhanced MRI in Pediatric and Neonatal Patient Population (<18years)
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