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临床试验/NCT01039818
NCT01039818已完成3 期

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

Hospital de Clinicas de Porto Alegre1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 1997年2月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Cure, defined as euthyroidism or permanent hypothyroidism based on FT4 measurements.

研究概览

简要总结

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

详细描述

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 In these patients, the therapeutic failure was 40.0% while in patients with smaller goiter was only 6.5% (P=0.005; unpublished).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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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).

研究组 & 干预措施

Radiodine-250µCi

Experimental

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

干预措施: Radioiodine (Radiation)

Radiodine-200µCi

Active Comparator

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.

干预措施: Radioiodine (Radiation)

结局指标

主要结局

Cure, defined as euthyroidism or permanent hypothyroidism based on FT4 measurements.

时间窗: 12 months

次要结局

  • Permanent hypothyroidism(12 months)
  • Euthyroidism(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Luiza Maia

PhD

Hospital de Clinicas de Porto Alegre

研究点 (1)

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