HypothyroidismPhase 4NCT03779906

Thyroid Function of Pediatric Subjects Following Isovue® Administration

A Phase 4 study testing Isovue in people with Hypothyroidism, run by Bracco Diagnostics, Inc at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages Up to 3 years
Conditions the study is for: Hypothyroidism
What is being tested?: Isovue
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 4 sitesUnited States
Study dates: 26 Mar 2019to 25 Mar 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 3 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Children's Hospital and Medical Center
Omaha, Nebraska, 68114
Phoenix Children's Hospital
Phoenix, Arizona, 85016

Other trials in United States

About this study

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

Conditions: Hypothyroidism
Being tested: Isovue
Keywords: hypothyroidism, ISOVUE, Iodinated Contrast Agent
Medical subject headings: Hypothyroidism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IsovueDrug
Also called IOPAMIDOL injection
Isovue will be given to all subjects per the standard of clinical care.

Study groups in NCT03779906
Study group	Role	What they receive
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. Receives: Drug: Isovue

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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
The proportion of subjects initiated on thyroid hormone replacement therapy.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 201925 Mar 2022

First posted19 Dec 2018
Study start26 Mar 2019
Primary completion15 Nov 2021
Study completion25 Mar 2022

Why it stopped: Formal release from PMR

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypothyroidismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03779906
Sponsor's protocol ID: IOP-120
Status last verified: Jul 2025
First submitted: 17 Dec 2018
Last updated: 30 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypothyroidism trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter Observational Study to Evaluate Thyroid Function of Pediatric Subjects From Birth to 3 Years Exposed to ISOVUE® (Iopamidol Injection)
ClinicalTrials.gov ID: NCT03779906
Acronym / sponsor ID: IOP-120
Conditions: Hypothyroidism
Keywords: hypothyroidism, ISOVUE, Iodinated Contrast Agent
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Formal release from PMR
Enrolment: 17 participants (actual)
Lead sponsor: Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
Study start: 26 Mar 2019 (actual)
Primary completion: 15 Nov 2021 (actual)
Study completion: 25 Mar 2022 (actual)
First posted: 19 Dec 2018 (actual)
Results: Posted 30 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ISOVUE	Experimental	Drug: IsovueIsovue 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.

Who may qualify

Ages: Up to 3 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IsovueAlso: IOPAMIDOL injectionIsovue will be given to all subjects per the standard of clinical care.	Drug	ISOVUE

Primary outcome

Abnormal Thyroid Function
Time frame: 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
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.

2 secondary outcomes

Hypothyroidism
Time frame: 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
Time frame: 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)

Results and safety

Results posted to the registry on 30 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ISOVUE	17	9

Primary outcome: Abnormal Thyroid Function

Time frame: 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. Count of participants. Unit: Participants

Measure	ISOVUE n = 17
Number of Patients with Abnormal TSH only at 1-month follow-up	0
Number of Patients with Abnormal TSH only at 2-month follow-up	0
Number of Patients with Abnormal TSH at 1 and 2 months' follow-up	0
Number of Patients with Normal TSH at All Follow-up Timepoints	17

Population analysed: Number of subjects evaluated for TFTs at baseline and post-baseline following intravascular administration of ISOVUE.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: As this was an Observational Study, untoward medical occurrences (i.e., adverse events) were monitored through completion of the exam with administration of ISOVUE, up to 1 week for subjects dosed as part of their routine standard of care.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ISOVUE	1 of 17 (5.9%)	0 of 17 (0%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypothyroidism

Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
Active, not recruitingPhase 4
Comparison of Two Timings of Levothyroxine Intake in Hypothyroid Patients: A Cross-over Randomized Control Trial
Hypothyroidism Primary
RecruitingObservational study
Understanding the Subnormal Rescue ofNeurological Development in Congenital Hypothyroidism (2022E5SZEM)
Congenital Hypothyroidism, Neurodevelopmental Disorders
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mary Luigia Storto, MD study director

Bracco Corporate

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Isovue in people with Hypothyroidism, run by Bracco Diagnostics, Inc at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Abnormal Thyroid Function (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03779906.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.