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

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.

Timeline

Start

2021-09-10

Primary completion

2023-07-05

Completion

2023-07-05

Outcome

Met primary endpoint

paper CONCLUSION: ZGrhTSH showed non-inferior performance in detecting radioiodine uptake and serum Tg PMID 40488858 ↗

release “临床 研究 结果 表明 ：ZGTSH004试验 的有 效性 和安 全性 结果 符合 预期 ，试验 达到 方案 预设 的主 要终 点.” zelgen.com ↗

Publications

• Lin Y, Wen Q, Fu W, Yang H, Gao Y, Li Z, Huang J, Gao Z, Wu J, Lv Z, Lu K, Chen Y, Yang A, OuYang W, Zhang S, Zhou H, Deng Z, Chen Z, Ding Y, Yuan C, Li L, Lin C, Sang S, Cheng Z, Cheng Y. RhTSH in aiding dynamic assessment in patients with differentiated thyroid Cancer. Eur J Nucl Med Mol Imaging. 2025 Dec;53(1):389-397. doi: 10.1007/s00259-025-07349-1. Epub 2025 Jun 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	rhTSH	Protein / enzyme biologic	0.9 mg	Intramuscular

Indications