Thyroid Function of Pediatric Subjects Following Isovue® Administration

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

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.

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.