Efficacy Evaluation of Strontium-89 Chloride for Differentiated Thyroid Cancer With Bone Metastases
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change of serum thyroglobulin antibody (TgAb) level
研究概览
简要总结
Using sensitive markers (such as thyroglobulin, etc) to evaluate the efficacy of strontium-89 chloride (Sr-89) in differentiated thyroid cancer with bone metastases with an aim to breaking out of its palliation effect for bone pain.
详细描述
Using biochemical markers (such as thyroglobulin), functional markers (such as change of tumor-background ratio on bone scan), etc to evaluate the efficacy of strontium-89 chloride (Sr-89) in differentiated thyroid cancer with bone metastases with an aim to breaking out of its palliation effect for bone pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of differentiated thyroid cancer
- •Positive uptake by bone metastases on bone scan
- •Planing to have Sr-89 treatment
排除标准
- •Having received treatment for bone metastases within one month of the study (such as radiotherapy, surgery, targeted therapy, chemotherapy, etc., among which denosumab and bisphosphate were allowed as basic treatment)
- •Having received radioactive iodine therapy within half a year before the study
- •There are bone related events, such as fracture, spinal cord compression, etc.
研究组 & 干预措施
Sr-89 treated group
Sr-89 treatment
干预措施: Sr-89 (Drug)
结局指标
主要结局
Change of serum thyroglobulin antibody (TgAb) level
时间窗: Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
Change of serum TgAb level
Change of serum thyroglobulin (Tg) level
时间窗: Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
Change of serum Tg level
Change of serum calcium level
时间窗: Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
Change of serum calcium level
Change of serum alkaline phosphatase (ALP) level
时间窗: Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
Change of ALP level
Change of standardized uptake value (SUV) on positron emission tomography/ computed tomography (PET/CT)
时间窗: Baseline, 3 months and 6 months
Change from baseline SUV on PET/CT at 3 months and 6 months
Change of tumor-background ratio on bone scan
时间窗: Baseline, 3 months and 6 months
Change from baseline tumor-background ratio on bone scan at 3 months and 6 months
次要结局
- Numerical rating scale (NRS) for pain(Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months)
- Structural change on image(Baseline, 3 months and 6 months)
- Analgesics(Up to 6 months)
- Skeletal related event (SRE)(Up to 6 months)
研究者
Yansong Lin
Vice director
Peking Union Medical College Hospital