Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT03779906
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
3 Years
Study:
NCT03779906
Study Brief:
Protocol Section:
NCT03779906