Bone Metastases, Thyroid Neoplasm Follicular
Conditions
Brief summary
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
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.
Interventions
DRUGSr-89
1. strontium-89 chloride treatment 2. periodical evaluation and follow-up
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Sr-89 treatment
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of standardized uptake value (SUV) on positron emission tomography/ computed tomography (PET/CT) | Baseline, 3 months and 6 months | Change from baseline SUV on PET/CT at 3 months and 6 months |
| Change of serum thyroglobulin antibody (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 TgAb 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 calcium level |
| Change of serum alkaline phosphatase (ALP) level | 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 tumor-background ratio on bone scan | Baseline, 3 months and 6 months | Change from baseline tumor-background ratio on bone scan at 3 months and 6 months |
| Change of serum thyroglobulin (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 Tg level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Scale of 0 to 10, 0=no pain, 10=worst imaginable pain |
| Skeletal related event (SRE) | Up to 6 months | Any SRE such as pathological fractures, surgery/radiotherapy for pain/prevention of fractures, hypercalcemia, and spinal cord compression. |
| Analgesics | Up to 6 months | Quantification of the use of analgesics and changes over time |
| Structural change on image | Baseline, 3 months and 6 months | Structural change on image at 3 months and 6 months |
Countries
China
Contacts
Primary ContactYan-Song Lin
Backup ContactXian-Feng Cao
Outcome results
None listed