Assessment of Immediate Adverse Reactions From Dotarem in Children Under 2 Years of Age
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|ClinicalTrials.gov Identifier: NCT02609919|
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : September 13, 2019
Our primary outcome is to assess the safety of Dotarem in children <2 years old up to 24 hours after Dotarem injection. Patients will be monitored for any adverse events that occur for 2 hours following the completion of the MRI exam. The type of event, time of onset, duration of symptoms, intensity of the reaction (mild, moderate, severe), causality (not related, probably related, related, definitely related, unclassifiable), and subsequent outcome (required treatment, favorable outcome, recovery with sequela, or death) will be documented. Parents will be given instruction sheets on who and when to call should any adverse event occur after discharge. Parents will be called by the radiology department the next day to identify any adverse events that occurred during the first 24 hours after discharge from the hospital.
Our secondary outcome is to assess image quality of the exam. The pre-contrast images will be compared to the combined pre- and post-contrast images following administration of Dotarem by radiologists who are blinded to the patients' clinical information to assess for improvement of image quality and delineation of structures with contrast.
|Condition or disease||Intervention/treatment|
|Adverse Reaction to Drug Allergic Reaction to Contrast Media||Drug: Gadoteric Acid|
|Study Type :||Observational|
|Actual Enrollment :||150 participants|
|Official Title:||Assessment of Immediate Adverse Reactions in Children Under 2 Years of Age Following Administration of Gadoteric Acid (Gd-DOTA or Dotarem)|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||July 18, 2019|
|Actual Study Completion Date :||July 19, 2019|
- Drug: Gadoteric Acid
MRI Contrast AgentOther Names:
- number and type of adverse drug events following the administration of gadoteric acid (Gd-DOTA or Dotarem) as well as when these reactions occur [ Time Frame: 18 months ]Safety and efficacy
- Image quality [ Time Frame: 18 months ]To assess whether lesion detection and characterization is improved with Dotarem compared to the noncontrast images.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609919
|United States, Missouri|
|Saint Louis University|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Shannon Farmakis, MD||St. Louis University School of Medicine|