Thyroid Function of Pediatric Subjects Following Isovue® Administration

Hypothyroidism Clinical Trial

Official title:

A Prospective, Multicenter Observational Study to Evaluate Thyroid Function of Pediatric Subjects From Birth to 3 Years Exposed to ISOVUE® (Iopamidol Injection)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03779906
• Other study ID #: IOP-120
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 26, 2019
• Est. completion date: January 31, 2025

Study information

• Verified date: July 2023
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 administration of ISOVUE for the required radiologic procedure as part of their standard of care.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1560
• Est. completion date: January 31, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

Drug:
• Isovue
Isovue will be given to all subjects per the standard of clinical care.

Locations

Country	Name	City	State
United States	Children's Hospital and Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal thyroid function	The primary outcome of this study is to evaluate the proportion of subjects, 0 to 3 years of age, developing abnormal thyroid function after administration of ISOVUE.	Day 1 to 2 months
Secondary	Hypothyroidism	To evaluate the proportion of subjects, 0 to 3 years of age, with hypothyroidism regardless of the need for thyroid hormone therapy after administration of ISOVUE.	Day 1 to 2 months
Secondary	Thyroid hormone replacement therapy	The proportion of subjects initiated on thyroid hormone replacement therapy.	Day 1 to 12 months