Thyroid Function of Pediatric Subjects Following Isovue® Administration

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multicenter Observational Study to Evaluate Thyroid Function of Pediatric Subjects From Birth to 3 Years Exposed to ISOVUE® (Iopamidol Injection)

Conditions
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Hypothyroidism

Intervention / Treatment
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* Drug: Isovue


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ISOVUE<br>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<br>* Isovue will be given to all subjects per the standard of clinical care.<br>* Other names: IOPAMIDOL injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal thyroid function | 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. | Day 1 to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypothyroidism | 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. | Day 1 to 2 months | 
| Thyroid hormone replacement therapy | The proportion of subjects initiated on thyroid hormone replacement therapy. | Day 1 to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypothyroidism, ISOVUE, Iodinated Contrast Agent