Thyroid Neoplasm FollicularPhase 4NCT05466812
Efficacy of Sr-89 for Differentiated Thyroid Cancer With Bone Metastases
A Phase 4 study testing Sr-89 in people with Thyroid Neoplasm Follicular and Bone Metastases, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Neoplasm Follicular, Bone Metastases
- What is being tested?
- Sr-89
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2022to 13 Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of differentiated thyroid cancer
- Positive uptake by bone metastases on bone scan
- Planing to have Sr-89 treatment
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Xian-Feng Cao contact
China1 site
Peking Union Medical College Hospital
Beijing
Yan-Song Lin, linys@pumch.cn
About this study
Official title: Efficacy Evaluation of Strontium-89 Chloride for Differentiated Thyroid Cancer With Bone Metastases
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.
Read the 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.
- Conditions
- Thyroid Neoplasm Follicular, Bone Metastases
- Being tested
- Sr-89
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sr-89Drug
Also called strontium-89 chloride
- strontium-89 chloride treatment
- periodical evaluation and follow-up
| Study group | Role | What they receive |
|---|---|---|
| Sr-89 treated group | Experimental | Sr-89 treatment Receives: Drug: Sr-89 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of serum thyroglobulin (Tg) level
Change of serum Tg level
Measured: Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
Change of serum thyroglobulin antibody (TgAb) level
Change of serum TgAb level
Measured: 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 calcium level
Measured: Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
Change of serum alkaline phosphatase (ALP) level
Change of ALP level
Measured: Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
Change of tumor-background ratio on bone scan
Change from baseline tumor-background ratio on bone scan at 3 months and 6 months
Measured: Baseline, 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
Measured: Baseline, 3 months and 6 months
Secondary outcomes (4)
Structural change on image
Structural change on image at 3 months and 6 months
Measured: Baseline, 3 months and 6 months
Numerical rating scale (NRS) for pain
Scale of 0 to 10, 0=no pain, 10=worst imaginable pain
Measured: Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
Skeletal related event (SRE)
Any SRE such as pathological fractures, surgery/radiotherapy for pain/prevention of fractures, hypercalcemia, and spinal cord compression.
Measured: Up to 6 months
Analgesics
Quantification of the use of analgesics and changes over time
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start13 Jul 2022 (estimated)
- Primary completion13 Jul 2024 (estimated)
- Study completion13 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Neoplasm FollicularStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Sr-89 treatment
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yansong Lin, Peking Union Medical College Hospital
- Investigators
- Yan-Song Lin, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466812
- Sponsor's protocol ID
- ZS-3477
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Strontium-89 Chloride for Differentiated Thyroid Cancer With Bone Metastases
- ClinicalTrials.gov ID
- NCT05466812
- Acronym / sponsor ID
- ZS-3477
- Conditions
- Thyroid Neoplasm Follicular, Bone Metastases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 13 Jul 2022 (estimated)
- Primary completion
- 13 Jul 2024 (estimated)
- Study completion
- 13 Jul 2025 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sr-89 treatment
| Arm | Type | Receives |
|---|---|---|
| Sr-89 treated group | Experimental | Drug: Sr-89Sr-89 treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of differentiated thyroid cancer
- Positive uptake by bone metastases on bone scan
- Planing to have Sr-89 treatment
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sr-89Also: strontium-89 chloride1. strontium-89 chloride treatment 2. periodical evaluation and follow-up | Drug | Sr-89 treated group |
Primary outcome
Change of serum thyroglobulin (Tg) level
Time frame: 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 thyroglobulin antibody (TgAb) level
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 3 months and 6 months
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)
Time frame: Baseline, 3 months and 6 months
Change from baseline SUV on PET/CT at 3 months and 6 months
4 secondary outcomes
Structural change on image
Time frame: Baseline, 3 months and 6 months
Numerical rating scale (NRS) for pain
Time frame: Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months
Skeletal related event (SRE)
Time frame: Up to 6 months
Analgesics
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xian-Feng Cao contact
Yan-Song Lin principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sr-89 in people with Thyroid Neoplasm Follicular and Bone Metastases, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan-Song Lin (861069155610, linys@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of serum thyroglobulin (Tg) level (time frame: Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.