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

NCT ID: NCT01039818

Last Updated: 2012-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-02-28

Study Completion Date

2011-08-31

Brief Summary

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

Detailed Description

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 In these patients, the therapeutic failure was 40.0% while in patients with smaller goiter was only 6.5% (P=0.005; unpublished).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

Conditions

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Graves Disease

Keywords

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Graves Disease Hyperthyroidism Radioiodine Clinical trial

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiodine-200µCi

A subgroup of patients with Graves' Disease and goiter ≥48ml treated with 200µCi of ¹³¹I/ml thyroid tissue, corrected by 24h-RAIU, from a randomized controlled trial run at our institution between February 1997 and March 2000, serves as a historical control.

Group Type ACTIVE_COMPARATOR

Radioiodine

Intervention Type RADIATION

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

Radiodine-250µCi

Patients with Graves' Disease and goiter ≥48ml, prospectively assigned to receive 250 µCi of ¹³¹I/ml thyroid tissue, corrected by 24h-RAIU.

Group Type EXPERIMENTAL

Radioiodine

Intervention Type RADIATION

A unique dose of 250µCi of ¹³¹I/ml/24-RAIU

Interventions

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Radioiodine

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

Intervention Type RADIATION

Radioiodine

A unique dose of 250µCi of ¹³¹I/ml/24-RAIU

Intervention Type RADIATION

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Rio Grande do Sul

OTHER

Sponsor Role collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Ana Luiza Maia

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana L Maia, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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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. doi: 10.1210/jcem.84.11.6149.

Reference Type BACKGROUND
PMID: 10566642 (View on PubMed)

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. doi: 10.1210/jcem.86.8.7707.

Reference Type BACKGROUND
PMID: 11502768 (View on PubMed)

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. doi: 10.1530/eje.0.1510467.

Reference Type BACKGROUND
PMID: 15476447 (View on PubMed)

Andrade VA, Gross JL, Maia AL. [Radioactive iodine therapy in Graves' hyperthyroidism]. Arq Bras Endocrinol Metabol. 2004 Feb;48(1):159-65. doi: 10.1590/s0004-27302004000100017. Epub 2004 Jun 1. Portuguese.

Reference Type BACKGROUND
PMID: 15611828 (View on PubMed)

Dora JM, Escouto Machado W, Andrade VA, Scheffel RS, Maia AL. Increasing the radioiodine dose does not improve cure rates in severe graves' hyperthyroidism: a clinical trial with historical control. J Thyroid Res. 2013;2013:958276. doi: 10.1155/2013/958276. Epub 2013 Jul 31.

Reference Type DERIVED
PMID: 23984185 (View on PubMed)

Other Identifiers

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07-055

Identifier Type: -

Identifier Source: org_study_id