Omaha, Nebraska 68114


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.



Primary Contact:

Study Director
Mary Luigia Storto, MD
Bracco Corporate

Julia Yureneva, MD
Phone: 609-514-2554

Backup Contact:


Location Contact:

Omaha, Nebraska 68114
United States

Travis Kruse, MD
Phone: 402-955-5602

Site Status: Recruiting

Data Source:

Date Processed: February 04, 2019

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