What side effects are associated with this type of intervention?

The most common treatment for hypothyroidism is levothyroxine, which can cause side effects such as palpitations, increased heart rate, anxiety, weight loss, and insomnia if the dose is too high. Iodinated contrast agents, like ISOVUE, used in radiologic procedures, can induce thyroid dysfunction, including hyperthyroidism or hypothyroidism, especially in patients with pre-existing thyroid conditions. These agents can also cause allergic reactions, ranging from mild (rash, itching) to severe (anaphylaxis). It is important for patients to discuss their thyroid health with their doctor before undergoing imaging procedures involving iodinated contrast.

What prior FDA approvals exist?

The FDA has approved several treatments for hypothyroidism, primarily focusing on thyroid hormone replacement therapies such as levothyroxine (LT4) and liothyronine (LT3). These treatments aim to normalize thyroid hormone levels in patients with underactive thyroid glands. While ISOVUE, an iodinated contrast agent, is used to enhance imaging in radiologic procedures and not directly for hypothyroidism treatment, it is important to note that iodine plays a crucial role in thyroid function. However, iodinated contrast agents are not typically used as a treatment for hypothyroidism but rather for diagnostic purposes in imaging studies.

What other types of research exist?

For hypothyroidism patients, gadolinium-based contrast agents (GBCAs) are a promising alternative to ISOVUE. GBCAs are non-iodinated and have been shown to be effective and safe for enhancing imaging in radiologic procedures. They are less likely to interfere with thyroid function compared to iodinated contrast agents.

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Isovue for Pediatric Thyroid Function

Phase 4

Waitlist Available

Research Sponsored by Bracco Diagnostics, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female from 0 to 3 years of age

Be younger than 18 years old

Must not have

On therapy with dopamine or any treatment which may affect the thyroid function testing results

Undergone radiation treatments to the head or neck

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to 12 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

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

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is an observational study focusing on the effects of Isovue on the thyroid, specific side effects aren't listed. However, general risks may include allergic reactions or other impacts related to contrast agent use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 3 years old or younger.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on medication that could affect thyroid tests.

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I have had radiation therapy on my head or neck.

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I am currently taking medication for my thyroid.

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I have been exposed to an iodine-based dye for scans or procedures within the last year.

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I was born with an underactive thyroid.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Abnormal thyroid function

Secondary study objectives

Hypothyroidism

Thyroid hormone replacement therapy

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ISOVUEExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Isovue

2014

Completed Phase 4

~150

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for hypothyroidism involve thyroid hormone replacement therapy, primarily using levothyroxine (T4) or a combination of levothyroxine and liothyronine (T3). These treatments work by supplementing the deficient thyroid hormones, thereby normalizing metabolic processes and energy levels in the body. This is crucial for hypothyroidism patients as it helps alleviate symptoms such as fatigue, weight gain, and cognitive impairment. While iodinated contrast agents like ISOVUE are used to enhance imaging in radiologic procedures, they are not treatments for hypothyroidism. However, they can influence thyroid function tests and may induce thyroid dysfunction in some patients, making it important for healthcare providers to monitor thyroid function closely in patients exposed to these agents.

Iodinated contrast prior to evaluation for thyrotoxicosis.