Clinical trial NCT05466812: Efficacy of Sr-89 for Differentiated Thyroid Cancer With Bone Metastases
Official title: Efficacy Evaluation of Strontium-89 Chloride for Differentiated Thyroid Cancer With Bone Metastases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Thyroid Neoplasm Follicular
Bone Metastases
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Sr-89 treatment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of serum thyroglobulin (Tg) level
timeFrame: Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
measure: Change of serum thyroglobulin antibody (TgAb) level
timeFrame: Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
measure: Change of serum calcium level
timeFrame: Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
measure: Change of serum alkaline phosphatase (ALP) level
timeFrame: Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
measure: Change of tumor-background ratio on bone scan
timeFrame: Baseline, 3 months and 6 months
measure: Change of standardized uptake value (SUV) on positron emission tomography/ computed tomography (PET/CT)
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: Structural change on image
timeFrame: Baseline, 3 months and 6 months
measure: Numerical rating scale (NRS) for pain
timeFrame: Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
measure: Skeletal related event (SRE)
timeFrame: Up to 6 months
measure: Analgesics
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yan-Song Lin
role: PRINCIPAL_INVESTIGATOR
References: