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NCT01269749 · ClinicalTrials.gov registry record · Phase 2

Radioactive Iodide Therapy for Pediatric Graves' Disease

A Phase 2 study of Graves Disease, sponsored by University of Florida.

Completed
Registry status
Phase 2
Development phase
19
Enrollment target
2
Study locations

NCT01269749: Completed Phase 2 study of Graves Disease, sponsored by University of Florida.

NCT01269749 is a Phase 2 study of Graves Disease that has completed, run by University of Florida. The registered enrollment target is 19 participants, below the 308-participant average among 11 other Graves Disease trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01269749, a Phase 2 study of Graves Disease, has completed, sponsored by University of Florida.

COMPLETED
Registry status
Phase 2
Development phase
19 participants
Enrollment target
2
Study locations

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

Primary Outcome

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.

Conditions Studied

Interventions

  • RADIATION RAI treatment
  • DRUG ATD Group

Study Locations (2)

Florida

  • University of Florida - Gainesville

Texas

  • Texas Childrens Hospital - Houston

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2010-10
Est. Completion 2016-06
Phase Phase 2
University of Florida

1,106 total trials

What the finished NCT01269749 record still lists

NCT01269749 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 308-participant average among 11 other Graves Disease trials with a reported enrollment target (94% lower).

The record links to 1 condition, with Graves Disease appearing as the primary indexed condition, and to 2 interventions - of which RAI treatment is the first listed.

NCT01269749 reports a single indexed study location in Florida, Texas.

Frequently Asked Questions

What is clinical trial NCT01269749 about?

NCT01269749 is a clinical study titled "Radioactive Iodide Therapy for Pediatric Graves' Disease". 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 ...

What is the current status of trial NCT01269749?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2010-10. Estimated completion is 2016-06.

What conditions does trial NCT01269749 study?

This clinical trial studies the following conditions: Graves Disease.

What interventions are being tested in trial NCT01269749?

The interventions under investigation include: RAI treatment (RADIATION), ATD Group (DRUG).

Who is sponsoring clinical trial NCT01269749?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01269749 being conducted?

This trial has 2 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Graves Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01269749's enrollment target sits among peer trials

19 9th of 11 higher than 3 of 11 other Graves Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Graves Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01269749, the US trial registry maintained by the National Library of Medicine. NCT01269749 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.