Isovue for Pediatric Thyroid Function

Overseen By Julia Yureneva, MD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Bracco Diagnostics, Inc

Must not be taking: Thyroid replacement, Dopamine

Disqualifiers: Allergy to ISOVUE, Congenital hypothyroidism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

17 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies if young children develop thyroid issues after using ISOVUE during their medical imaging procedures.

Research Team

Mary Luigia Storto, MD

Principal Investigator

Bracco Corporate

Eligibility Criteria

This trial is for children aged 0 to 3 who need a radiologic exam with Isovue as part of their usual care and have normal thyroid function tests. They can't join if they're allergic to Isovue, have congenital hypothyroidism, had head/neck radiation, are on thyroid drugs or treatments affecting the thyroid, used iodinated products recently, or had contrast agents within a year.

Inclusion Criteria

Written informed consent is obtained from the subject's parent(s) or legally acceptable representative(s) who are willing to comply with the protocol requirements

My thyroid function tests are normal.

I am 3 years old or younger.

Exclusion Criteria

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

I am on medication that could affect thyroid tests.

I have had radiation therapy on my head or neck.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Radiologic Procedure

Participants undergo a radiologic procedure with ISOVUE administration as part of their standard of care

1 day

Observation

Participants are monitored for abnormal thyroid function after ISOVUE administration

2 months

Extended Follow-up

Participants are monitored for the need for thyroid hormone replacement therapy

12 months

Treatment Details

Interventions

• Isovue

Trial Overview The study observes young patients after using Isovue in imaging procedures to see how often it causes abnormal thyroid function. It's an observational study where kids receive standard care and researchers track changes in their thyroid levels afterwards.

Participant Groups

Group I: ISOVUE Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Bracco Diagnostics, Inc

Lead Sponsor

Trials

62

Recruited

9,500+

Diana Bracco

Bracco Diagnostics, Inc

Chief Executive Officer since 1999

Degree in Chemistry from the University of Pavia

Alberto Spinazzi

Bracco Diagnostics, Inc

Chief Medical Officer since 2023

MD