Efficacy of Sr-89 for Differentiated Thyroid Cancer With Bone Metastases

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy Evaluation of Strontium-89 Chloride for Differentiated Thyroid Cancer With Bone Metastases

Conditions
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Thyroid Neoplasm Follicular, Bone Metastases

Intervention / Treatment
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* Drug: Sr-89


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of differentiated thyroid cancer Positive uptake by bone metastases on bone scan Planing to have Sr-89 treatment Exclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Sr-89 treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sr-89 treated group<br>Sr-89 treatment | Drug: Sr-89<br>* strontium-89 chloride treatment periodical evaluation and follow-up<br>* Other names: strontium-89 chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |