The Effect of 0.1 mg Recombinant Human Thyrotropin (rhTSH) on Thyroid Radioiodine-uptake and the Degree of Goiter Reduction Following 131I-therapy, in Patients With Benign Non-toxic Nodular Goiter. A Randomized, Double-blind, Placebo-controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- An intra-individual comparison of the thyroid 131I-uptake before and after stimulation with rhTSH /placebo
研究概览
简要总结
The study aims at clarifying (in a randomized, double-blinded design):
- Whether stimulation with 0.1 mg rhTSH 24, 48 or 72 hours before induction of a 131I-tracer dosis increases the 131I uptake in patients with atoxic multinodular goitre and to study which time interval is the most optimal (Part I)
- Whether patients suffering from atoxic multinodular goitre obtains a corresponding goitre reduction compared with a control group when stimulating with 0.1 mg rh TSH 24, 48 or 72 hours before 131I therapy and when reducing the thyroid radiation dose to 50 Gy (Part II)
The two studies will be carried out successively on the same patient population. The 131I uptake will be carried out first followed by the I therapy itself. The patients are compared with a placebo-treated control group going through the same course of treatment, but the 131I dosis will be 100 Gy (standard treatment). After the 131I therapy, all patients are followed during one year with a regular ultrasound scan of the thyroid gland and control of the metabolic status. The patient satisfaction is monitored by the use of a visual-analogue-scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Apart from benign non-toxic goiter no other serious illness
- •Signed proof of participation
排除标准
- •Treatment with Levothyroxine
- •Former 131I-therapy
- •A thyroid volume above 100 ml or a retro-clavicular component
- •Unsafe contraception
- •Pregnancy or breastfeeding
- •Participation in another clinical trial
- •Previous allergic reaction toward rhTSH
- •Suspicion of malignancy in the thyroid gland either by clinical examination, laboratory findings (a raised serum calcitonin or ionized calcium)or by fine-needle aspiration biopsy
- •Physically or mental condition making it impossible to participate
- •Acute ischemic heart attach within the last 3 months
- •Alcohol and/or drug addicts
研究组 & 干预措施
rhTSH
proceeded by 0.1 mg rhTSH
干预措施: Recombinant human thyrotropin (Thyrogen) (Drug)
rhTSH
proceeded by 0.1 mg rhTSH
干预措施: recombinant human TSH (Drug)
Placebo
1 ml isotonic saline
干预措施: isotonic saline = placebo (Other)
结局指标
主要结局
An intra-individual comparison of the thyroid 131I-uptake before and after stimulation with rhTSH /placebo
时间窗: 24 and 96 hours after tracer administration
An inter-individual comparison of the thyroid 131I uptake between those who receive placebo and those who receive rhTSH
时间窗: 24 and 96 hours after tracer administration
An estimation of which time-interval, injecting rhTSH, that is more favourable before 131I therapy (24 hours, 48 hours or 72 hours)
时间窗: 24 and 96 hours after tracer administration
A comparison of the degree of goiter reduction when patients are prestimulated with rhTSH and receive a thyroid 131I dose of 50 Gy or when receiving conventional 131I, receiving a thyroid dose of 100 Gy
时间窗: 3, 6, 9 and 12 months after 131I therapy
次要结局
- Patient satisfaction (Visual Analogue Scale) before, 3 months post 131I therapy, and at the end of follow-up (1 year).(baseline, 3 and 12 months after 131I therapy)
- A registration of adverse effects following rhTSH/placebo(All adverse effects occuring within one year follow-up)
- Development of TPOab or TSHRab(At 12 months follow-up)
- Thyroid function(At 12 months follow up.)
研究者
Steen Bonnema
Consultant, phd, DMsc
Odense University Hospital