Thyroid Function of Pediatric Subjects Following Isovue® Administration



Status:Recruiting
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:Any - 3
Updated:1/18/2019
Start Date:February 1, 2019
End Date:January 31, 2025
Contact:Julia Yureneva, MD
Email:julia.yureneva@diag.bracco.com
Phone:609-514-2554

Use our guide to learn which trials are right for you!

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.
We found this trial at
1
site
Omaha, Nebraska 68114
Phone: 402-955-5602
?
mi
from
Omaha, NE
Click here to add this to my saved trials