NCT04971473

Comparison of the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal

An Open, Single-arm, Self-controlled, Multi-center Phase 3 Study to Compare the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is A non-blinded trial. Oral radioiodine was given 24 hours after the second injection of rhTSH, and scanning was done 48 hours after the radioiodine administration. Each patient was scanned first following rhTSH and then scanned after thyroid hormone withdrawal.

Conditions

• Differentiated Thyroid Cancer

Interventions

Type	Name	Description
BIOLOGICAL	rhTSH	Scanning was done 48 hours after the radioiodine administration. Each patient was scanned first following rhTSH and then scanned after thyroid hormone withdrawal.

Timeline

• Start date: 2021-09-10
• Primary completion: 2023-07-05
• Completion: 2023-07-05
• First posted: 2021-07-21
• Last updated: 2024-03-28

Locations

1 site across 1 country: China