Comparison of Different Doses of 131I in Severe Graves' Hyperthyroidism

September 4, 2012 updated by: Ana Luiza Maia, Hospital de Clinicas de Porto Alegre

Comparison of Different Doses of 131I in Severe Graves' Hyperthyroidism: A Clinical Trial With Historical Control

The purpose of this study is to determine whether higher doses of radioiodine increase treatment efficacy in severe Graves' disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Graves' disease (GD) is the most frequent cause of hyperthyroidism, affecting mainly women aged 40-60 years. Radioiodine (¹³¹I), introduced in 1941, has become a cornerstone in the treatment of GD hyperthyroidism. Because of its safety, low costs and rapid effect, it is considered a first line therapy in the United States. However, treatment failure occurs in about 15-25% of patients treated with radioiodine. Patients not cured with the first dose of radioiodine usually present severe hyperthyroidism, characterized by large goiter, high 24-hour radioiodine uptake (24h-RAIU) and very high levels of thyroid hormones. We have previously shown that large goiter (≥48ml) is an independent predictor of treatment failure. In these patients, the therapeutic failure was 40.0% while in patients with smaller goiter was only 6.5% (P=0.005; unpublished). It is generally accepted that higher doses of radioiodine improves cure rates. Indeed, a recent meta-analysis found a correlation between radioiodine dose and therapeutic success in GD patients. To our knowledge, there are no published studies evaluating cure rates with different radioiodine doses in severe GD.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-003
        • Thyroid Unit, Endocrine Division, Hospital de Clínicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consecutive patients with a recent diagnosis of Graves' disease and goiter ≥ 48 ml, attending the Endocrine Division at Hospital de Clinicas de Porto Alegre are eligible.

Exclusion Criteria:

  • Patients with previous treatment with radioiodine or thyroidectomy,
  • Signs of moderate or severe ophthalmopathy (proptosis > 22 mm, ophthalmoplegia, chemosis, or lagophthalmos),
  • Severe heart disease (symptomatic coronary heart disease, class III heart failure, New York Heart Association criteria),
  • Debilitating conditions, and
  • Large and compressive goiters (> 150 g).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Radiodine-200µCi
A subgroup of patients with Graves' Disease and goiter ≥48ml treated with 200µCi of ¹³¹I/ml thyroid tissue, corrected by 24h-RAIU, from a randomized controlled trial run at our institution between February 1997 and March 2000, serves as a historical control.
Radiation: Radioiodine
A unique dose of 200µCi of ¹³¹I/ml/24-RAIU
Radiation: Radioiodine
A unique dose of 250µCi of ¹³¹I/ml/24-RAIU
Experimental: Radiodine-250µCi
Patients with Graves' Disease and goiter ≥48ml, prospectively assigned to receive 250 µCi of ¹³¹I/ml thyroid tissue, corrected by 24h-RAIU.
Radiation: Radioiodine
A unique dose of 200µCi of ¹³¹I/ml/24-RAIU
Radiation: Radioiodine
A unique dose of 250µCi of ¹³¹I/ml/24-RAIU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cure, defined as euthyroidism or permanent hypothyroidism based on FT4 measurements.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Euthyroidism
Time Frame: 12 months
12 months
Permanent hypothyroidism
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Federal University of Rio Grande do Sul

Investigators

  • Principal Investigator: Ana L Maia, MD, PhD, Thyroid Unit, Endocrine Division, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1997

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

December 24, 2009

First Submitted That Met QC Criteria

December 24, 2009

First Posted (Estimate)

December 25, 2009

Study Record Updates

Last Update Posted (Estimate)

September 6, 2012

Last Update Submitted That Met QC Criteria

September 4, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-055

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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