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
|Condition or disease||Intervention/treatment||Phase|
|Hypothyroidism||Drug: Isovue||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1560 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Isovue will be given to all subjects per the standard of clinical care.
Other Name: IOPAMIDOL injection
- 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.
- 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.
- Thyroid hormone replacement therapy [ Time Frame: Day 1 to 12 months ]The proportion of subjects initiated on thyroid hormone replacement therapy.
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
|Contact: Julia Yureneva, MDfirstname.lastname@example.org|
|United States, Nebraska|
|Children's Hospital and Medical Center||Recruiting|
|Omaha, Nebraska, United States, 68114|
|Contact: Travis Kruse, MD 402-955-5602 email@example.com|
|Contact: Kelly Erickson, MPH 402-559-1039 firstname.lastname@example.org|
|Study Director:||Mary Luigia Storto, MD||Bracco Corporate|