Thyroid Unit, Endocrine Division, Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
NCT Number: NCT01039818
The purpose of this study is to determine whether higher doses of radioiodine increase treatment efficacy in severe Graves' disease.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 3
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
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 In these patients, the therapeutic failure was 40.0% while in patients with smaller goiter was only 6.5% (P=0.005; unpublished).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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A unique dose of 200µCi of ¹³¹I/ml/24-RAIU
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Hospital de Clinicas de Porto Alegre
Other
Comparison of Different Doses of 131I in Severe Graves' Hyperthyroidism: A Clinical Trial With Historical Control
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