Radioactive Iodide Therapy for Pediatric Graves' Disease - Full Text View

Purpose

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.

Condition	Intervention	Phase
Graves' Disease	Radiation: RAI treatment Drug: ATD Group	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Radioactive Iodide Therapy for Pediatric Graves' Disease

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Iodide

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:

Dosimetry Studies [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

Cancer risk assessment [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	300
Study Start Date:	October 2010
Estimated Study Completion Date:	August 2018
Estimated Primary Completion Date:	August 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).	Radiation: 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).
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).	Drug: 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).

Arms

Assigned Interventions

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).

Radiation: 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).

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).

Drug: 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).

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

> 18 years.
Smoking parents.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269749

Locations

United States, Florida
University of Florida	Recruiting
Gainesville, Florida, United States, 32610
Contact: Scott Rivkees, MD 352-273-9001 srivkees@ufl.edu
Contact: Cathy Hoover 352-273-9001 choover@ufl.edu
Principal Investigator: Scott Rivkees, MD
United States, Texas
Texas Childrens Hospital	Recruiting
Houston, Texas, United States, 77030
Contact: Ioanna Athanassaki, MD 832-822-3777 ioannaa@bcm.edu
Principal Investigator: Ioanna Athanassaki, M.D.

Sponsors and Collaborators

University of Florida

Baylor College of Medicine

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Scott A Rivkees, MD

Yale University

More Information

No publications provided

Responsible Party:	University of Florida
ClinicalTrials.gov Identifier:	NCT01269749 History of Changes
Other Study ID Numbers:	0904005064, 1R01FD003707
Study First Received:	October 29, 2010
Last Updated:	April 15, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Florida:

Hyperthyroidism
Antithyroid drugs
Cancer
Dosimetry
Children

Additional relevant MeSH terms:

Graves Disease
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism

Autoimmune Diseases
Immune System Diseases
Antithyroid Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013