Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- TSH level at the end of study
研究概览
简要总结
The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation to test for cancer recurrence. One of the options is to stop L-thyroxin replacement for several weeks. Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients.
详细描述
The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation for the measurement of thyreoglobulin and/or total body scanning. There are two principal methods to obtain TSH elevation: 1) injection of recombinant human TSH , and 2) to stop L-thyroxin replacement for several (3-4) weeks. As use of recombinant TSH is rather expensive, this method is not feasible in many countries. The problem with stopping L-thyroxin is development of severe hypothyroidism for several weeks with concomitant symptoms and signs.
Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients with fixed dose of L-thyroxin. Concomitantly, blood tests and symptoms and signs of hypothyroidism will be obtained to get information about possible deviations during treatment with low dose of thyroxin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Differentiated thyroid cancer
- •treated by thyroidectomy and at least 1 ablation with 131-I > 5 months ago
- •TSH < 4 imU/L
排除标准
- •Pregnancy
- •Known metastasis
研究组 & 干预措施
L-thyroxin
this is one arm study
干预措施: L-thyroxin (Drug)
结局指标
主要结局
TSH level at the end of study
时间窗: 4-6 weeks
The percentage of patients obtaining TSH level at least 30 imU/L at the end of study period. Blood tests will be obtained after 4 weeks. If TSH \> 30 the patient has completed the study. If TSH \< 30 patient will continue for 1 week and blood tests will be obtained after week 5. If TSH \> 30 the patient has completed the study. If TSH \< 30 patient will be monitored during 1 week and blood tests will be obtained after 6 weeks.
次要结局
- change in Billewitz index during the study(4-6 weeks)