Omaha, Nebraska 68114


Purpose:

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.


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.


NCT ID:

NCT03779906


Primary Contact:

Study Director
Mary Luigia Storto, MD
Bracco Corporate

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


Backup Contact:

N/A


Location Contact:

Omaha, Nebraska 68114
United States

Travis Kruse, MD
Phone: 402-955-5602
Email: tkruse@childrenspmaha.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.