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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 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.

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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

Conditions Studied

Graves Disease

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

Sponsor

University of Florida

1,106 total trials

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What the Registry Record Tells You About NCT01269749

The ClinicalTrials.gov registry entry for NCT01269749 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 308-participant average among 11 other Graves Disease trials with a reported enrollment target (94% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.