Radioactive Iodide Therapy for Pediatric Graves' Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Dosimetry Studies
研究概览
简要总结
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
详细描述
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 with 131I is known. (4) The investigators have working relationships with collaborators at these sites. Based on the relative patient volumes of Baylor and University of Florida, the investigators anticipate that 70% of patients will come from Baylor and 30% from University of Florida. Calculations supporting the sample size are detailed in each of the two aims below.
Patient eligibility. Eligibility criteria include the following:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Age <18 years at the time of GD disease diagnosis.
- •Non-smoking parents.
排除标准
- •> 18 years.
- •Smoking parents.
研究组 & 干预措施
RAI treatment
Characteristics of study population. We 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, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).
干预措施: RAI treatment (Radiation)
ATD Group
Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). 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, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).
干预措施: ATD Group (Drug)
结局指标
主要结局
Dosimetry Studies
时间窗: 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.
次要结局
- Cancer Risk Assessment(4 years)