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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01039818
Other study ID # 07-055
Secondary ID
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 In these patients, the therapeutic failure was 40.0% while in patients with smaller goiter was only 6.5% (P=0.005; unpublished).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


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
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