The Effect of Different Calculated Doses of I-131 in Treatment of Patients With Grave's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- change of thyroid related hormones blood level from baseline at 1,3,6 and 12 month
研究概览
简要总结
Radioactive iodine (RAI) administration is an effective and completely established treatment modality in hyperthyroidism including Graves' disease. Despite the long experience with radioiodine for hyperthyroidism, controversy remains regarding the optimal dose of iodine that is required to achieve long-term euthyroidism. The fixed activity administration method does not optimize the therapy, giving often too high or too low radiation to the gland, but the optimal dose per gram of thyroid mass in calculated activity administration method is also under much debates. This prospective study has been designed in order to compare the effect of different calculated doses of radioiodine on Graves' disease treatment outcome.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Age 18-65 hyperthyroid patients (Graves'disease)
排除标准
- •Pregnancy or lactation
研究组 & 干预措施
Low dose of I-131
Patients with Graves' disease who will be treated with I-131, using 100 microcurie per gram (uCi/gr) of thyroid weight
干预措施: Low dose of I-131 (Drug)
Intermediate dose
Patients with Graves' disease who will be treated with 150 microcurie (uCi) of I-131 per gram of thyroid weight.
干预措施: Intermediate dose (Drug)
High dose
Patients with Graves' disease who will be treated with I-131 using 200 uCi/gr of thyroid weight.
干预措施: High dose (Drug)
结局指标
主要结局
change of thyroid related hormones blood level from baseline at 1,3,6 and 12 month
时间窗: 1,3,6,12 month
thyroid-stimulating hormone (TSH), T4, T3
次要结局
- Rate of hypothyroidism status at 1, 3,6 and 12 month post RAI therapy(1,3,6,12 month)
研究者
S.R.ZAKAVI
Head of Nuclear Medicine Research Center
Mashhad University of Medical Sciences