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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01039818
Enrollment
30
Registered
2009-12-25
Start date
1997-02-28
Completion date
2011-08-31
Last updated
2012-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graves Disease

Keywords

Graves Disease, Hyperthyroidism, Radioiodine, Clinical trial

Brief summary

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

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 In these patients, the therapeutic failure was 40.0% while in patients with smaller goiter was only 6.5% (P=0.005; unpublished).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

Interventions

RADIATIONRadioiodine

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

Sponsors

Federal University of Rio Grande do Sul
CollaboratorOTHER
Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Cure, defined as euthyroidism or permanent hypothyroidism based on FT4 measurements.12 months

Secondary

MeasureTime frame
Euthyroidism12 months
Permanent hypothyroidism12 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026