Radioactive Iodide Therapy for Pediatric Graves' Disease

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators hypothesize that 131I is an effective therapy for children with Graves' Disease (GD) and will not be associated with long-term cancer risks when used in older children, but may be associated with excessive levels of whole body radiation in young children. To address issues of 131I safety and cancer risk in the pediatric population, the investigators propose to: (1) Perform dosimetry to assess whole body radiation exposure following 131I therapy in children treated for GD (2) the investigators will assess chromosome translocation as related to age and dose of 131I.

It is anticipated that these studies will provide new insights into RIA use in children and provide important information about radiation exposure associated 131I use in children. As such, these studies are expected to result in new recommendations for 131I use in the treatment of pediatric GD.

Funding Source - FDA OOPD

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: Baylor College of Medicine
• Treatments: Antithyroid Agents

Criteria

Inclusion Criteria:

1. A diagnosis of GD based on initial laboratory studies showing a suppressed TSH (i.e. <0.01); high total T3, high total T4 and/or free T4 level; an elevated thyroid stimulating immunoglobulin (TSI) titer; increased and diffuse uptake of 123I, 131I, or 99Tc in the thyroid gland.

2. Age <18 years at the time of GD disease diagnosis.

3. Non-smoking parents.

Exclusion Criteria:

1. > 18 years.

2. Smoking parents.