Isovue for Pediatric Thyroid Function

No longer recruiting at 3 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how Isovue, a contrast agent used during radiologic procedures, affects thyroid function in young children. Researchers seek to determine if children aged 0 to 3 years with normal thyroid function before the procedure develop any thyroid issues after receiving Isovue. The trial includes children already scheduled for a radiologic exam requiring Isovue, and they must have had normal thyroid tests beforehand. As a Phase 4 trial, Isovue is already FDA-approved and proven effective, and this research helps clarify its benefits for more patients.

Do I need to stop my current medications to join the trial?

If your child is currently on thyroid replacement therapy or taking dopamine, they cannot participate in the trial. The protocol does not specify other medications, but these are the main ones mentioned.

What is the safety track record for Isovue?

Research has shown that Isovue is generally safe for children, but some risks exist. In a study with 76 children, only two experienced side effects, accounting for about 2.6% of cases. This indicates that most children do not encounter negative effects from the treatment.

However, Isovue can cause hypothyroidism, a condition where the thyroid gland underperforms, in children under 3 years old. This risk is particularly significant for children with certain health issues, such as congenital heart disease.

Since the FDA has approved Isovue for use in imaging tests, there is confidence in its safety. Nonetheless, checking thyroid function after its use is recommended, especially in young children with existing health risks. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for pediatric thyroid function, which typically involve hormone replacement therapies or iodine supplementation, Isovue is unique because it is an iodine-based contrast agent used in radiologic procedures. Researchers are excited about Isovue because it allows for detailed imaging of the thyroid, potentially providing clearer insights into thyroid function and structure. This could lead to more precise diagnoses and tailored treatments, which is a significant advancement over current methods.

What is the effectiveness track record for Isovue in pediatric thyroid function?

Research has shown that Isovue, an iodine-based contrast dye, is effective and commonly used in medical imaging. However, its impact on thyroid function in young children raises concerns. Some studies suggest that iodine from Isovue can temporarily affect thyroid function in children under three years old. The FDA advises monitoring the thyroid health of these young patients after they receive Isovue due to the risk of hypothyroidism, a condition where the thyroid doesn't produce enough hormones. Despite these concerns, Isovue remains an important tool for imaging when used carefully. ^{1 4 6 7 8}

Who Is on the Research Team?

Mary Luigia Storto, MD

Principal Investigator

Bracco Corporate

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03779906

Thyroid Function of Pediatric Subjects Following Isovue® ... Study Overview. This is a Phase IV prospective, multicenter, observational study to estimate the proportion of subjects 0 to 3 years of age who develop ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12367033/

Thyroid Monitoring following Intravenous Iodinated ... Outcome measures included the percentage of patients with TFTs completed within our system's EMR within 3 weeks of contrast administration ( ...

3. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/018735s070lbl.pdf

ISOVUE® (Iopamidol Injection) - accessdata.fda.gov The results of PBI and radioactive iodine uptake studies, which depend on iodine estimations, will not accurately reflect thyroid function for up to 16 days ...

4. fda.gov fda.gov/media/157241/download

FDA recommends thyroid monitoring in babies and young ... FDA recommends monitoring of pediatric patients from birth through 3 years for the possibility of hypothyroidism or a temporary decrease in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4318903/

A Review: Radiographic Iodinated Contrast Media-Induced ... This review will discuss the thyroidal response after acute exposure to excess iodine; contrast iodine-induced thyroid dysfunction; risks of iodine-induced ...

6. bracco.com bracco.com/us-en-2022-04-27-spc-isovue

ISOVUE® (iopamidol) injection, for intra-arterial or ... Adverse Reactions in Pediatric Patients In a clinical trial with 76 pediatric patients undergoing angiocardiography, two adverse reactions (2.6%) were reported ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/iopamidol-injection-route/description/drg-20150965

Iopamidol (injection route) - Side effects & uses This medicine may cause hypothyroidism (underactive thyroid) in children 3 years of age and younger. Children with congenital (from birth) heart ...

8. isovue.com isovue.com/

ISOVUE - ISOVUE ISOVUE® (Iopamidol Injection) Imaging Bulk Package is the first FDA-approved contrast medium designed for multidose use. Learn more today.