NCT06431620

Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Adjuvant Diagnosis in Patients With Locally Advanced/Metastatic Differentiated Thyroid Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-06-30
• Primary completion: 2026-05-31
• Completion: 2026-12-31
• First posted: 2024-05-28
• Last updated: 2024-05-28

Locations

1 site across 1 country: China