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 |
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.
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
Click here to add this to my saved trials