Radioactive Iodide Therapy for Pediatric Graves' Disease

NCT01269749 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: IRB2012001511R01FD003707
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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

Conditions

Graves' Disease

Keywords

Hyperthyroidism; Antithyroid drugs; Cancer; Dosimetry; Children

Outcome Measures

Primary Outcomes (1)

• Dosimetry Studies

  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.

  4 years

Secondary Outcomes (1)

• Cancer Risk Assessment

  4 years

Study Arms (2)

RAI treatment

OTHER

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

ATD Group

OTHER

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

Interventions

RAI treatment RADIATION

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).

RAI treatment

ATD Group DRUG

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).

ATD Group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \> 18 years.
• Smoking parents.

Sponsors & Collaborators

• University of Florida: lead
• Baylor College of Medicine: collaborator

Study Sites (2)

University of Florida

Gainesville, Florida, 32610, United States

Location

Texas Childrens Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Graves Disease; Hyperthyroidism; Neoplasms

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr Scott Rivkees
• Organization: University of Florida

srivkees@ufl.edu

352-273-9001

Study Officials

• Scott A Rivkees, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: January 4, 2011
• Study Start: October 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 6, 2017
• Results First Posted: November 6, 2017

Record last verified: 2017-10

Locations

US (2)