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Completed

NCT Number: NCT01039818

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Thyroid Unit, Endocrine Division, Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

About this study

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 In these patients, the therapeutic failure was 40.0% while in patients with smaller goiter was only 6.5% (P=0.005; unpublished).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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Radioiodine

Radiation

A unique dose of 200µCi of ¹³¹I/ml/24-RAIU

Primary outcomes

  1. Cure, defined as euthyroidism or permanent hypothyroidism based on FT4 measurements.

    Time frame: 12 months

Secondary outcomes

  1. Euthyroidism

    Time frame: 12 months

  2. Permanent hypothyroidism

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Federal University of Rio Grande do Sul

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
2011
Study completion
2011
First posted
Dec 25, 2009
Registry last updated
Sep 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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