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Assessment of Immediate Adverse Reactions From Dotarem in Children Under 2 Years of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609919
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Shannon G. Farmakis, M.D., St. Louis University

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Gadoteric Acid
    MRI Contrast Agent
    Other Names:
    • Gd-DOTA
    • Dotarem


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Image quality [ Time Frame: 18 months ]
    To assess whether lesion detection and characterization is improved with Dotarem compared to the noncontrast images.



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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children under 2 years of age requiring MRI with Contrast
Criteria

Inclusion Criteria:

  • Any patient under 2 years of age undergoing an MRI exam of the neuraxis or body with or without and with contrast as part of their standard of care.
  • Included patients may be scheduled with simultaneous sedation for the MRI.
  • Nonsedated patients also qualify for the study.

Exclusion Criteria:

  • Patients 2 years of age or older.
  • Patients receiving an MRI exam without contrast.
  • Patients with a GFR <30.
  • Patients with known renal failure or prior gadolinium based contrast agent hypersensitivity reaction.
  • Patients who receive an MRI exam using a different gadolinium-based contrast agent.
  • Patients who are not accompanied by a parent will not be included.
  • Patients who are unable to complete the MRI exam prior to contrast administration will be excluded.

Information from the National Library of Medicine

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


Locations
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United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
St. Louis University
Investigators
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Principal Investigator: Shannon Farmakis, MD St. Louis University School of Medicine

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Responsible Party: Shannon G. Farmakis, M.D., Assistant Professor, St. Louis University
ClinicalTrials.gov Identifier: NCT02609919    
Other Study ID Numbers: Dotarem Study
26250 ( Other Identifier: Saint Louis University Institutional Review Board )
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Keywords provided by Shannon G. Farmakis, M.D., St. Louis University:
study of contrast reaction in children under 2 years of age
safety
Additional relevant MeSH terms:
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Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Immune System Diseases
Chemically-Induced Disorders
Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action