Thyroid Function of Pediatric Subjects Following Isovue® Administration
Stopped early · Phase 4
Conditions studied: Hypothyroidism
In brief
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.
Key facts
- Study ID
- NCT03779906
- Run by
- Bracco Diagnostics, Inc
- People needed
- 17
- Starts
- 2019-03-26
- Expected to finish
- 2022-03-25
- Last updated by the study team
- 2025-07-30
Who can join
Age: any, up to 3. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Phoenix Children's Hospital — Phoenix, Arizona, United States
- Children's Hospital and Medical Center — Omaha, Nebraska, United States
- Children's Hospital Medical Center of Akron — Akron, Ohio, United States
- Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.