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

Graves Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039818
• Other study ID #: 07-055
• Status: Completed
• Phase: Phase 3
• First received: December 24, 2009
• Last updated: September 4, 2012
• Start date: February 1997
• Est. completion date: August 2011

Study information

• Verified date: September 2012
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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 In these patients, the therapeutic failure was 40.0% while in patients with smaller goiter was only 6.5% (P=0.005; unpublished).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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graves Disease
• Hyperthyroidism

Intervention

Radiation:
• Radioiodine
A unique dose of 200µCi of ¹³¹I/ml/24-RAIU
• Radioiodine
A unique dose of 250µCi of ¹³¹I/ml/24-RAIU

Locations

Country	Name	City	State
Brazil	Thyroid Unit, Endocrine Division, Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Andrade VA, Gross JL, Maia AL. [Radioactive iodine therapy in Graves' hyperthyroidism]. Arq Bras Endocrinol Metabol. 2004 Feb;48(1):159-65. Epub 2004 Jun 1. Review. Portuguese. — View Citation

Andrade VA, Gross JL, Maia AL. Effect of methimazole pretreatment on serum thyroid hormone levels after radioactive treatment in Graves' hyperthyroidism. J Clin Endocrinol Metab. 1999 Nov;84(11):4012-6. — View Citation

Andrade VA, Gross JL, Maia AL. Serum thyrotropin-receptor autoantibodies levels after I therapy in Graves' patients: effect of pretreatment with methimazole evaluated by a prospective, randomized study. Eur J Endocrinol. 2004 Oct;151(4):467-74. — View Citation

Andrade VA, Gross JL, Maia AL. The effect of methimazole pretreatment on the efficacy of radioactive iodine therapy in Graves' hyperthyroidism: one-year follow-up of a prospective, randomized study. J Clin Endocrinol Metab. 2001 Aug;86(8):3488-93. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure, defined as euthyroidism or permanent hypothyroidism based on FT4 measurements.		12 months	No
Secondary	Euthyroidism		12 months	No
Secondary	Permanent hypothyroidism		12 months	No