Pretreatment With Recombinant Human Thyrotropin (rhTSH) for the Effect on Thyroid Size and Function, and for the Effect of Radioiodine Treatment in Patients With Nodular Goiter. Prospective, Randomized Double-blinded Trials.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Ultrasonography/MR of the thyroid gland/benign goiter, in order to determine thyroid size after intervention.
研究概览
简要总结
The trials in this protocol deals with the effect of pretreatment with rhTSH on radioiodine treatment of thyroid size and function, in patients with nontoxic and toxic nodular goiter. It is an introduction of a novel principle, based on prospective, randomized double blind investigations. Attached to this, we investigate the acute effects of rhTSH on thyroid size (measured by ultrasonography), both in healthy individuals and in patients with nontoxic nodular goiter. Thus, the investigations are divided into 4 categories listed below:
- Prospective randomized double blind study of pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine in nontoxic multinodular goiter.
- Prospective randomized double blind study of the pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine on thyroid size and function in patients with a very large (>100 ml) nontoxic or toxic goiter.
- Does administration of 0.9 mg recombinant human TSH affect thyroid function and volume in healthy individuals? A randomized double-blind cross-over trial.
- Does administration of 0.3 mg recombinant human TSH affect thyroid function and volume in healthy individuals and in patients with multinodular non-toxic goiter? A randomized double-blind cross-over trial.
As a final note we investigate, in a pilot-study; 5. The influence of rhTSH on thyroid radioiodine uptake in patients with hyperthyroidism treated with continuous block-replacement therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers with an intact thyroid gland
- •Patients with nontoxic/subtoxic nodular goiter confirmed by ultrasonography
- •Patients with toxic nodular goiter
- •Patients with Graves' disease
排除标准
- •Treatment with drugs that alter thyroid function or size (the last 3 months prior to inclusion)
- •Prior 131I treatment
- •Alcohol, medicine or drug abuse
- •Pregnancy or lactation
- •No safe contraception
- •Participation in another clinical trial
- •Allergic reaction towards rhTSH
- •Fine needle biopsy without valid diagnostic criteria for benign disease
- •Suspicion of malignancy, increased ionized serum calcium and/or serum calcitonin
- •Incontinence
- •Physically or psychic condition that hinders corporation
- •Ischemic attack up till 3 months before inclusion
结局指标
主要结局
Ultrasonography/MR of the thyroid gland/benign goiter, in order to determine thyroid size after intervention.
次要结局
未报告次要终点