Trial record 8 of 67 for:    "Graves Disease"

Radioactive Iodide Therapy for Pediatric Graves' Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Florida
Sponsor:
Collaborators:
Baylor College of Medicine
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01269749
First received: October 29, 2010
Last updated: July 15, 2014
Last verified: July 2014
  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.

Funding Source - FDA OOPD


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:


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).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 University of Florida
  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: July 15, 2014
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
Autoimmune Diseases
Endocrine System Diseases
Exophthalmos
Eye Diseases
Goiter
Hyperthyroidism
Immune System Diseases
Orbital Diseases
Thyroid Diseases
Antithyroid Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014