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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sr-89 treated group | Experimental | Sr-89 treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sr-89 | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change of serum thyroglobulin (Tg) level | Change of serum Tg level | Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months |
| Change of serum thyroglobulin antibody (TgAb) level | Change of serum TgAb level | 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 calcium level | Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months |
| Change of serum alkaline phosphatase (ALP) level | Change of ALP level | Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months |
| Change of tumor-background ratio on bone scan | Change from baseline tumor-background ratio on bone scan at 3 months and 6 months | Baseline, 3 months and 6 months |
| Change of standardized uptake value (SUV) on positron emission tomography/ computed tomography (PET/CT) | Change from baseline SUV on PET/CT at 3 months and 6 months | Baseline, 3 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Structural change on image | Structural change on image at 3 months and 6 months | Baseline, 3 months and 6 months |
| Numerical rating scale (NRS) for pain | Scale of 0 to 10, 0=no pain, 10=worst imaginable pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan-Song Lin | Contact | 861069155610 | linys@pumch.cn | |
| Xian-Feng Cao | Contact | 861069156874 |
| Name | Affiliation | Role |
|---|---|---|
| Yan-Song Lin | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | China |
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| ID | Term |
|---|---|
| C025700 | strontium chloride |
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Sr-89 treatment
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| Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months |
| Skeletal related event (SRE) | Any SRE such as pathological fractures, surgery/radiotherapy for pain/prevention of fractures, hypercalcemia, and spinal cord compression. | Up to 6 months |
| Analgesics | Quantification of the use of analgesics and changes over time | Up to 6 months |