Effect of the Radioiodine Dose in Thyroid Ablation- A Randomized Comparison of 1110 MBq to 3700 MBq
试验速览
- 阶段
- 3 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Cumulative number of radioactive iodine administrations
研究概览
简要总结
The thyroid cells take up iodine, and radioactive iodine is commonly used to irradiate residual thyroid tissue and thyroid cancer following surgical removal of the thyroid gland (thyroidectomy). A whole body radioactive iodine scanning is usually carried out after thyroidectomy to assess the amount of thyroid tissue left behind at surgery (that might still contain cancer), and to evaluate the presence of iodine avid lesions elsewhere in the body (that might be cancer metastases). A large dose of radioactive iodine is often given, still the optimal iodine dose to ablate the thyroid remnant after surgery is not known. In this study, two radioactive iodine doses are compared in the ablation of the thyroid remnant, a smaller (1110 MBq) dose and a larger (3700 MBq) dose. The study participants are randomly allocated using a 1:1 ratio to receive either the smaller or the larger radioactive iodine dose. These treatments are compared for safety, adverse effects, and the need for subsequent repeat treatments. The individual absorbed radiation doses are measured. The study hypothesis is that fewer repeat radioiodine treatments might be needed after the larger dose, but the larger dose might be associated with a higher frequency of adverse events.
详细描述
The study participants are randomly allocated to receive either a 1110 MBq or a 3700 MBq dose of radioiodine (131I) approximately 5 weeks after thyroidectomy. Thyroxin substitution is initiated only after administration of radioactive iodine. Treatment efficacy is monitored using serum thyroglobulin measurements and whole body radioiodine scanning. The absorbed radiation dose at the thyroid remnant and the biological half-life of radioactive iodine are measured with SPECT, 131I iodine detector and a Geiger counter.
Treatment related adverse events are collected using structured forms 4 to 5 days, 2 weeks and 3 months after administration of radioiodine. The need for a repeat treatment is assessed 4 to 6 months after the first administration of radioiodine. The criteria for a repeat radioiodine treatment are serum thyroglobulin > 1 ug/L and/or presence of abnormal radioiodine uptake in a whole body radioiodine scanning, which is carried out following a 4-week interruption of thyroxin supplementation or following administration of rhTSH.
Number of patients: 160
Aims of the study:
- To find out weather the risk for second radioiodine treatment differs with two dose levels of radioiodine: 1110 MBq or 3700 MBq.
- To study possible differences in the adverse effects in the treatment groups. Also days at hospital are counted.
- To analyse the effect of absorbed radiation dose to the treatment results
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
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Radioactive iodine 1,1 GBq
Low activity of radioiodine, 1,1 GBq
干预措施: Radioactive iodine (Drug)
Radioactive iodine 3,7 GBq
Routine activity of radioiodine, 3,7 GBq
干预措施: Radioactive iodine (Drug)
结局指标
主要结局
Cumulative number of radioactive iodine administrations
时间窗: 15 yrs
次要结局
- Adverse events(15 yrs)
- Absorbed radiation dose(15 yrs)
- Cancer recurrence(15 yrs)
研究者
Hanna Mäenpää
Chief of Department
University of Helsinki