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

NCT02609919 | Completed DMC

• 2 other identifiers: Dotarem Study26250
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Reaction to Drug; Allergic Reaction to Contrast Media

Keywords

study of contrast reaction in children under 2 years of age; safety

Outcome Measures

Primary Outcomes (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

  Safety and efficacy

  18 months

Secondary Outcomes (1)

• Image quality

  18 months

Interventions

Gadoteric Acid DRUG

MRI Contrast Agent

Also known as: Gd-DOTA, Dotarem

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children under 2 years of age requiring MRI with Contrast

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate; gadoterate meglumine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Shannon Farmakis, MD

  St. Louis University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 20, 2015
• Study Start: January 1, 2016
• Primary Completion: July 18, 2019
• Study Completion: July 19, 2019
• Last Updated: September 13, 2019

Record last verified: 2019-09

Locations

US (1)