The Safety and Effectiveness of rhTSH in Radioiodine Treatment for Patients With Differentiated Thyroid Cancer.

  • STATUS
    Recruiting
  • participants needed
    120
  • sponsor
    Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Updated on 5 December 2022

Summary

This is a randomized, open, parallel controlled, multi-center clinical trial; 120 subjects were randomly assigned to the test group and the control group according to 3:1.

Description

This study was conducted in patients with differentiated thyroid cancer who had undergone near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation (use of radioiodine to remove any remaining thyroid tissue). One group of patients who took thyroid hormone medicine and were euthyroid [i.e. their thyroid stimulating hormone (TSH) levels are normal], and received injections of Thyrogen (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high), and were given oral radioiodine. All patients received the same amount of radioactive iodine (30mCi1.5mCi or 1.11GBq of 131I). Approximately 9 months later, whole body scans were performed on all patients to learn whether the thyroid remnants had been successfully ablated.

Details
Condition Differentiated Thyroid Cancer
Treatment Radioactive Iodine, Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH)
Clinical Study IdentifierNCT04447183
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd
Last Modified on5 December 2022

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