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Radioactive Iodide Therapy

RAI treatment for Graves Disease

Phase 2
Waitlist Available
Led By Scott A Rivkees, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study 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

Eligible Conditions
  • Graves Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dosimetry Studies
Secondary outcome measures
Cancer Risk Assessment

Trial Design

2Treatment groups
Experimental Treatment
Group I: RAI treatmentExperimental Treatment1 Intervention
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).
Group II: ATD GroupExperimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RAI treatment
2010
Completed Phase 2
~20
ATD Group
2010
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,349 Previous Clinical Trials
720,110 Total Patients Enrolled
Baylor College of MedicineOTHER
1,002 Previous Clinical Trials
6,002,765 Total Patients Enrolled
Scott A Rivkees, MDPrincipal InvestigatorUniversity of Florida

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Radioactive Iodide Therapy for Pediatric Graves' Disease
2010. "Radioactive Iodide Therapy for Pediatric Graves' Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01269749.
~1 spots leftby May 2025
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