Status:
TERMINATED
Thyroid Function of Pediatric Subjects Following Isovue® Administration
Lead Sponsor:
Bracco Diagnostics, Inc
Conditions:
Hypothyroidism
Eligibility:
All Genders
Up to 3 years
Phase:
PHASE4
Brief Summary
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 admini...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2022
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03779906
Start Date
March 26 2019
End Date
March 25 2022
Last Update
July 30 2025
Active Locations (4)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Children's Hospital and Medical Center
Omaha, Nebraska, United States, 68114
3
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
4
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425