91´óÉñ

Clinical Trial

Offered by: 91´óÉñ Children's Health, Jacksonville
Location: Jacksonville, Fla.

Trial Name

Evaluate Thyroid Function After Isovue (Iopamidol Injection)

What is the trial about?

This is a research study to see if children up to 3 years old who are given Isovue as standard of care for x-ray procedures develop an abnormal thyroid. Study participation will last about two months. Participation could be longer (up to 1 year) if the thyroid function test (after Isovue) comes back.

Who can participate?

Children 0 to 3 years of age who will receive Isovue during an X-ray examination as part of their standard of care.

What is involved?

The following procedures would be done only because you are taking part in this research study. These procedures will be at no cost to you:

• Reading and signing a consent.
• Answering questions about your child’s sex/race and medical history.
• Answering questions about your exposure to iodine while pregnant with your child.
• 2 mL of blood (less than ½ of a teaspoon) collection for testing your child’s thyroid function.
• Laboratory testing for the thyroid function test.
• Collecting information about any unexpected medical occurrence associated with Isovue administration.
• Collecting follow up information at 6 months and 12 months (after Isovue) only if your child has an abnormal thyroid test after Isovue.

Study participation will last about two months. Participation could be longer (up to 1 year) if the thyroid function test (after Isovue) comes back abnormal.