Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Adjuvant Diagnosis in Patients With Locally Advanced/Metastatic Differentiated Thyroid Cancer
NCT06431620 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2024-05-28
Summary
Exogenous injection of recombinant human thyroid stimulating hormone (rhTSH) can elevate TSH in the short term (2 days) to meet the requirements of diagnostic 131I SPECT/CT whole-body scans. Antiangiogenic tyrosine kinase inhibitors (TKI) couuld alter the uptake of radioactive 131I in locally advanced or metastatic differentiated thyroid cancer. rhTSH can help to perform the diagnostic 131I SPECT/CT whole-body scans before and after the TKI usage. rhTSH can reduce the risk of tumor progression caused by thyroid hormone withdrawal period and the side effects of hypothyroidism also caused by thyroid hormone withdrawal, and clarify the 131I uptake change after TKI treatment.
Conditions
- Recombinant Human Thyroid Stimulating Hormone
Interventions
- DRUG
-
Recombinant Human Thyroid Stimulating Hormone
recombinant human thyrotropin (rhTSH) injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days.
Sponsors & Collaborators
-
Nanjing First Hospital, Nanjing Medical University
lead OTHER
Principal Investigators
-
Feng Wang · Nanjing First Hospital, Nanjing Medical University
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-30
- Primary Completion
- 2026-05-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
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