Clinical Trial: Radioactive Iodide Therapy for Pediatric Graves' Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Radioactive Iodide Therapy for Pediatric Graves' Disease

Brief 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


Detailed Summary:

Primary Aims. The investigators propose to assess the safety of 131I use in children with hyperthyroidism due to Graves' disease (GD). The investigators will measure whole body radiation exposure following 131II therapy in children treated for GD. The investigators will assess the effects of GD treatment on chromosome structure.

These studies will involve collaborative efforts with Dr. Patrick Zanzonico (Memorial Sloan-Kettering Cancer Center), who is an expert in 131I dosimetry and Dr. James Tucker (Wayne State University), who is an expert in cytogenetic effects of radiation. The studies will involve children treated for GD at University of Florida University and Baylor University. These studies have been designed with the help of the University of Florida Center for Clinical Investigation, Biostatistics Support Unit, which will be involved in data analysis.

Characteristics of study population. The investigators will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, the investigators stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).

Two sites will enroll patients to achieve the desired sample size: Baylor College of Medicine and University of Florida University. These sites have been selected for the following reasons. (1) These are large centers where radioactive iodide has been used for decades. (2) Each site has treated large number of children with radioactive iodide. (3) Each site has computerized patient databases and contact information for children treated wit
Sponsor: University of Florida

Current Primary Outcome: Dosimetry Studies [ Time Frame: 4 years ]

Primary Aims. We propose to (1) perform dosimetry to assess whole body radiation exposure following 131II therapy in children treated for GD; and (2) assess the effects of 131I treatment of GD (treated with medication or surgery) on chromosome translocations.


Original Primary Outcome: Same as current

Current Secondary Outcome: Cancer risk assessment [ Time Frame: 4 years ]

Secondary Aims. (i) As a follow-up to the first primary aim, we will calculate potential cancer risk from the radiation exposure data; and (ii) within the analyses for the second primary aim, we will evaluate chromosomal translocation in children treated with 131I vs. not, as related to age and dose of 131I.


Original Secondary Outcome: Same as current

Information By: University of Florida

Dates:
Date Received: October 29, 2010
Date Started: October 2010
Date Completion:
Last Updated: December 2, 2016
Last Verified: December 2016