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

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

Brief 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.

Detailed 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 (30mCi±1.5mCi 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.


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, open, parallel controlled, multi-center clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of the Safety and Effectiveness of rhTSH in Radioiodine Treatment for Patients With Differentiated Thyroid Cancer.
Estimated Study Start Date: April 2021
Estimated Primary Completion Date: July 1, 2023
Estimated Study Completion Date: August 1, 2023

Arm:
- Experimental: Test group
- Experimental: Control group

View full details