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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05466812
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Sr-89 treatmentSr-89 treatment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy Evaluation of Strontium-89 Chloride for Differentiated Thyroid Cancer With Bone Metastases
Anticipated Study Start Date :
Jul 13, 2022
Anticipated Primary Completion Date :
Jul 13, 2024
Anticipated Study Completion Date :
Jul 13, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of serum thyroglobulin (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 Tg level

    2. Change of serum thyroglobulin antibody (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 TgAb level

    3. 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 calcium level

    4. Change of serum alkaline phosphatase (ALP) level [Through study completion, an average of 1 week in the first months and 1 month thereafter, up to 6 months]

      Change of ALP level

    5. Change of tumor-background ratio on bone scan [Baseline, 3 months and 6 months]

      Change from baseline tumor-background ratio on bone scan at 3 months and 6 months

    6. Change of standardized uptake value (SUV) on positron emission tomography/ computed tomography (PET/CT) [Baseline, 3 months and 6 months]

      Change from baseline SUV on PET/CT at 3 months and 6 months

    Secondary Outcome Measures

    1. Structural change on image [Baseline, 3 months and 6 months]

      Structural change on image at 3 months and 6 months

    2. 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]

      Scale of 0 to 10, 0=no pain, 10=worst imaginable pain

    3. Skeletal related event (SRE) [Up to 6 months]

      Any SRE such as pathological fractures, surgery/radiotherapy for pain/prevention of fractures, hypercalcemia, and spinal cord compression.

    4. Analgesics [Up to 6 months]

      Quantification of the use of analgesics and changes over time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing China

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yansong Lin, Vice director, Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT05466812
    Other Study ID Numbers:
    • ZS-3477
    First Posted:
    Jul 20, 2022
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Thyroid Neoplasms
    Bone Neoplasms
    Bone Marrow Diseases
    Thyroid Diseases

    Study Results

    No Results Posted as of Jul 20, 2022