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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
rhTSH: 0.9 mg IM daily on two consecutive days;radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral
radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Ablation success rate by Diagnostic Whole Body Scan (DxWBS)
In the THW state (TSH≥30mU/L), DxWBS showed the proportion of subjects who did not see radioactive iodine uptake in the thyroid gland.
Time frame: at week 36
Serum thyroglobulin (Tg) levels
In the THW state (TSH≥30mU/L), the proportion of patients with Tg levels \<1ng/mL and neck B-ultrasound negative during rhTSH stimulation accounted for all subjects.
Time frame: at week 36
Adverse Event
Classification and degree of adverse events
Time frame: up to week 40 ± 7 day
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