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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bone Metastases; Thyroid Neoplasm Follicular
• Intervention / Treatment: Drug: Sr-89

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yan-Song Lin; Phone Number: 861069155610; Email: linys@pumch.cn
• Study Contact Backup: Name: Xian-Feng Cao; Phone Number: 861069156874

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital
    • Contact: Yan-Song Lin; Email: linys@pumch.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sr-89 treated group; Sr-89 treatment	Drug: Sr-89; strontium-89 chloride treatment; periodical evaluation and follow-up; Other Names: strontium-89 chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structural change on image	Structural change on image at 3 months and 6 months	Baseline, 3 months and 6 months
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
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
Analgesics	Quantification of the use of analgesics and changes over time	Up to 6 months

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Yan-Song Lin, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 13, 2022
• Primary Completion (ANTICIPATED): July 13, 2024
• Study Completion (ANTICIPATED): July 13, 2025

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (ACTUAL): July 20, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Hematologic Diseases; Endocrine Gland Neoplasms; Musculoskeletal Diseases; Head and Neck Neoplasms; Neoplastic Processes; Bone Diseases; Neoplasm Metastasis; Thyroid Diseases; Bone Neoplasms; Bone Marrow Diseases; Thyroid Neoplasms
• Other Study ID Numbers: ZS-3477

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No