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

Phase 4

Not yet recruiting

• Conditions: Thyroid Neoplasm Follicular; Bone Metastases
• Interventions: Drug: Sr-89

• Registration Number: NCT05466812
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-12
• Study Start: 2022-07-13
• Study First Submitted QC: 2022-07-18
• Last Update Submitted: 2022-07-18
• Study First Posted: 2022-07-20
• Last Update Posted: 2022-07-20
• Primary Completion: 2024-07-13
• Study Completion: 2025-07-13

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sr-89 treated group	Sr-89	Sr-89 treatment

Primary Outcome Measures

Name	Time	Method
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 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
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 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 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

Secondary Outcome Measures

Name	Time	Method
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
Structural change on image	Baseline, 3 months and 6 months	Structural change on image at 3 months and 6 months
Analgesics	Up to 6 months	Quantification of the use of analgesics and changes over time
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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China