Thyroid Function of Pediatric Subjects Following Isovue® Administration

NCT03779906 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IOP-120
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 4

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

Keywords

hypothyroidism; ISOVUE; Iodinated Contrast Agent

Outcome Measures

Primary Outcomes (1)

• Abnormal Thyroid Function

  The primary outcome of this study was to evaluate the proportion of subjects, 0 to 3 years of age, with abnormal TSH values post-baseline following administration of ISOVUE.

  Day 1 (day dosed with intravascular administration of ISOVUE as part of their standard of care examination) to 1-month follow-up or 2-month follow-up

Secondary Outcomes (2)

• Hypothyroidism

  Day 1 (day dosed with intravascular administration of ISOVUE as part of their standard of care examination) to 1-month follow-up or 2-month follow-up

• Thyroid Hormone Replacement Therapy

  Day 1 (day dosed with intravascular administration of ISOVUE as part of their standard of care examination) to 1-month follow-up or 2-month follow-up to 6- to 12 months follow-up (if applicable)

Study Arms (1)

ISOVUE

EXPERIMENTAL

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.

Drug: Isovue

Interventions

Isovue DRUG

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

Also known as: IOPAMIDOL injection

ISOVUE

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (4)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Children's Hospital and Medical Center

Omaha, Nebraska, 68114, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Hypothyroidism

Interventions

Iopamidol

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Maria Luigia Storto, MD, Executive Director Medical Planning and Management X-ray products
• Organization: Bracco Diagnostics Inc.

MariaLuigia.Storto@diag.bracco.com

609-514-2262

Study Officials

• Mary Luigia Storto, MD

  Bracco Corporate

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: March 26, 2019
• Primary Completion: November 15, 2021
• Study Completion: March 25, 2022
• Last Updated: July 30, 2025
• Results First Posted: July 30, 2025

Record last verified: 2025-07

Locations

US (4)