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Thyroid Function of Pediatric Subjects Following Isovue® Administration

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ClinicalTrials.gov Identifier: NCT03779906
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

Brief Summary:
This is a Phase IV prospective, multicenter, observational study to estimate the proportion of subjects 0 to 3 years of age who develop abnormal thyroid function after exposure to intravascular administration of ISOVUE for the required radiologic procedure as part of their standard of care.

Condition or disease Intervention/treatment Phase
Hypothyroidism Drug: Isovue Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1560 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Prospective, Multicenter Observational Study to Evaluate Thyroid Function of Pediatric Subjects From Birth to 3 Years Exposed to ISOVUE® (Iopamidol Injection)
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : January 31, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Iopamidol

Arm Intervention/treatment
Experimental: ISOVUE
Isovue will be given to all subjects per the standard of clinical care.The specific iodine concentration and volume of ISOVUE used during the radiologic procedure will depend on the type of procedure and the standards in place at the site where the procedure is performed.
Drug: Isovue
Isovue will be given to all subjects per the standard of clinical care.
Other Name: IOPAMIDOL injection




Primary Outcome Measures :
  1. Abnormal thyroid function [ Time Frame: Day 1 to 2 months ]
    The primary outcome of this study is to evaluate the proportion of subjects, 0 to 3 years of age, developing abnormal thyroid function after administration of ISOVUE.


Secondary Outcome Measures :
  1. Hypothyroidism [ Time Frame: Day 1 to 2 months ]
    To evaluate the proportion of subjects, 0 to 3 years of age, with hypothyroidism regardless of the need for thyroid hormone therapy after administration of ISOVUE.

  2. Thyroid hormone replacement therapy [ Time Frame: Day 1 to 12 months ]
    The proportion of subjects initiated on thyroid hormone replacement therapy.



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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is male or female from 0 to 3 years of age;
  • Is scheduled to undergo a radiologic examination that requires intravascular administration of ISOVUE as part of his/her standard of care;
  • Has normal baseline thyroid function tests (TSH, total T3, total T4, and fT4) performed at a local laboratory with blood sample obtained within one week prior to ISOVUE administration;
  • Written informed consent is obtained from the subject's parent(s) or legally acceptable representative(s) (according to local regulations) who are willing to comply with the protocol requirements.

Exclusion Criteria:

  • Has any known allergy to one or more of the ingredients of ISOVUE;
  • Has been diagnosed with congenital hypothyroidism;
  • Has undergone radiation treatments to the head or neck;
  • Is currently on thyroid replacement therapy;
  • Is on therapy with dopamine or any treatment which may affect the thyroid function testing results;
  • Has been exposed to any topical iodinated product within 30 days prior to enrollment in the present study;
  • Has been exposed to an iodinated contrast agent within 1 year prior to enrollment in the present study, including any administration of iodinated contrast agents during placement of a central line;
  • Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.

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): NCT03779906


Contacts
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Contact: Julia Yureneva, MD 609-514-2554 julia.yureneva@diag.bracco.com

Locations
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United States, Nebraska
Children's Hospital and Medical Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: Travis Kruse, MD    402-955-5602    tkruse@childrenspmaha.org   
Contact: Kelly Erickson, MPH    402-559-1039    kelly.erickson@unmc.edu   
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
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Study Director: Mary Luigia Storto, MD Bracco Corporate

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Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT03779906     History of Changes
Other Study ID Numbers: IOP-120
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bracco Diagnostics, Inc:
hypothyroidism
ISOVUE
Iodinated Contrast Agent
Additional relevant MeSH terms:
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Hypothyroidism
Thyroid Diseases
Endocrine System Diseases