Back to resultsEfficacy of Sr-89 for Differentiated Thyroid Cancer With Bone Metastases
Primary Purpose
Thyroid Neoplasm Follicular, Bone Metastases
Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sr-89
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Neoplasm Follicular
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.
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sr-89 treated group
Arm Description
Sr-89 treatment
Outcomes
Primary Outcome Measures
Change of serum thyroglobulin (Tg) level
Change of serum Tg level
Change of serum thyroglobulin antibody (TgAb) level
Change of serum TgAb level
Change of serum calcium level
Change of serum calcium level
Change of serum alkaline phosphatase (ALP) level
Change of ALP level
Change of tumor-background ratio on bone scan
Change from baseline tumor-background ratio on bone scan at 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
Secondary Outcome Measures
Structural change on image
Structural change on image at 3 months and 6 months
Numerical rating scale (NRS) for pain
Scale of 0 to 10, 0=no pain, 10=worst imaginable pain
Skeletal related event (SRE)
Any SRE such as pathological fractures, surgery/radiotherapy for pain/prevention of fractures, hypercalcemia, and spinal cord compression.
Analgesics
Quantification of the use of analgesics and changes over time
Full Information
NCT ID
NCT05466812
First Posted
July 12, 2022
Last Updated
July 18, 2022
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05466812
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 13, 2022 (Anticipated)
Primary Completion Date
July 13, 2024 (Anticipated)
Study Completion Date
July 13, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Neoplasm Follicular, Bone Metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Sr-89 treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sr-89 treated group
Arm Type
Experimental
Arm Description
Sr-89 treatment
Intervention Type
Drug
Intervention Name(s)
Sr-89
Other Intervention Name(s)
strontium-89 chloride
Intervention Description
strontium-89 chloride treatment
periodical evaluation and follow-up
Primary Outcome Measure Information:
Title
Change of serum thyroglobulin (Tg) level
Description
Change of serum Tg level
Time Frame
Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
Title
Change of serum thyroglobulin antibody (TgAb) level
Description
Change of serum TgAb level
Time Frame
Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
Title
Change of serum calcium level
Description
Change of serum calcium level
Time Frame
Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
Title
Change of serum alkaline phosphatase (ALP) level
Description
Change of ALP level
Time Frame
Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
Title
Change of tumor-background ratio on bone scan
Description
Change from baseline tumor-background ratio on bone scan at 3 months and 6 months
Time Frame
Baseline, 3 months and 6 months
Title
Change of standardized uptake value (SUV) on positron emission tomography/ computed tomography (PET/CT)
Description
Change from baseline SUV on PET/CT at 3 months and 6 months
Time Frame
Baseline, 3 months and 6 months
Secondary Outcome Measure Information:
Title
Structural change on image
Description
Structural change on image at 3 months and 6 months
Time Frame
Baseline, 3 months and 6 months
Title
Numerical rating scale (NRS) for pain
Description
Scale of 0 to 10, 0=no pain, 10=worst imaginable pain
Time Frame
Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
Title
Skeletal related event (SRE)
Description
Any SRE such as pathological fractures, surgery/radiotherapy for pain/prevention of fractures, hypercalcemia, and spinal cord compression.
Time Frame
Up to 6 months
Title
Analgesics
Description
Quantification of the use of analgesics and changes over time
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan-Song Lin
Phone
861069155610
Email
linys@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xian-Feng Cao
Phone
861069156874
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan-Song Lin
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan-Song Lin
Email
linys@pumch.cn
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Sr-89 for Differentiated Thyroid Cancer With Bone Metastases
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