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

Bone Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05466812
• Other study ID #: ZS-3477
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 13, 2022
• Est. completion date: July 13, 2025

Study information

• Verified date: July 2022
• Source: Peking Union Medical College Hospital
• Contact: Yan-Song Lin
• Phone: 861069155610
• Email: linys[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 13, 2025
• Est. primary completion date: July 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Neoplasm Metastasis
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Sr-89
strontium-89 chloride treatment periodical evaluation and follow-up

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Structural change on image	Structural change on image at 3 months and 6 months	Baseline, 3 months and 6 months
Secondary	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
Secondary	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
Secondary	Analgesics	Quantification of the use of analgesics and changes over time	Up to 6 months