Thyroid Function of Pediatric Subjects Following Isovue® Administration

NCT ID: NCT03779906

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-26
• Study Completion Date: 2022-03-25

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

Conditions

Hypothyroidism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ISOVUE

Isovue will be given to all subjects per the standard of clinical care.The specific iodine concentration and volume of ISOVUE used during the radiologic procedure will depend on the type of procedure and the standards in place at the site where the procedure is performed.

Group Type: EXPERIMENTAL

Isovue

Intervention Type: DRUG

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

Interventions

Isovue

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

Intervention Type: DRUG

Other Intervention Names

IOPAMIDOL injection

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.

• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Luigia Storto, MD

Role: STUDY_DIRECTOR

Bracco Corporate

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

IOP-120

Identifier Type: -

Identifier Source: org_study_id