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

NCT05466812 | Unknown Phase 4

• 1 other identifier: ZS-3477
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Neoplasm Follicular; Bone Metastases

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Structural change on image

  Baseline, 3 months and 6 months

• 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

• Skeletal related event (SRE)

  Up to 6 months

• Analgesics

  Up to 6 months

Study Arms (1)

Sr-89 treated group

EXPERIMENTAL

Sr-89 treatment

Drug: Sr-89

Interventions

Sr-89 DRUG

1. strontium-89 chloride treatment 2. periodical evaluation and follow-up

Also known as: strontium-89 chloride

Sr-89 treated group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of differentiated thyroid cancer
• Positive uptake by bone metastases on bone scan
• Planing to have Sr-89 treatment

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Interventions

strontium chloride

Study Officials

• Yan-Song Lin

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan-Song Lin

CONTACT

861069155610; linys@pumch.cn

Xian-Feng Cao

CONTACT

861069156874

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director

Model Details: Sr-89 treatment

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 20, 2022
• Study Start: July 13, 2022
• Primary Completion: July 13, 2024
• Study Completion: July 13, 2025
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

CN (1)