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

 -  Pathological diagnosis of differentiated thyroid cancer, including papillary thyroid
 cancer (including papillary carcinoma follicular subtype), follicular thyroid cancer,
 and Hurthle cell thyroid cancer;

 -  Patients who were at 18~75 years old (male or female).

 -  Patients with a total or near-total thyroidectomy within 12 weeks prior to enrollment
 and plan to performing radioactive iodine((131)Ⅰ) thyroid remnant ablation.

 -  Serum TSH ≤ 0.5 mU/L；

 -  Women of childbearing age are HCG-negative;

 -  Low iodine diet before enrollment for more than 4 weeks;

 -  Patients are voluntarily enrolled, and written informed consent forms can be used for
 treatment and visits as required by the program.

 Exclusion Criteria:

 -  Any significant clinical and laboratory abnormalities (eg, severe cardiopulmonary
 disease, hepatic insufficiency, renal function Incomplete, congestive heart failure,
 advanced lung disease or advanced cardiovascular and cerebrovascular disease, active
 infection);

 -  Patients who have used any water-soluble radiographic contrast agent intravenously,
 underwent intrathecal iodine angiography or gallbladder iodine imaging within 3 months
 before administration;

 -  Taken/eaten within 4 weeks prior to administration Drugs/foods that affect iodine
 uptake or metabolism, such as multivitamins, glucocorticoids, diuretics, lithium,
 thiouracil, tazobactam, algae, iodine (except thyroid hormone replacement therapy);

 -  Before administration Stroke, unstable angina (CCS class II or higher), atrial
 fibrillation or medication (within beta blocker or digoxin) within 6 months Patients
 with a history of arrhythmia;

 -  Pregnant or lactating women;

 -  Patients who are allergic to rhTSH and its excipients;

 -  Patients with positive infection-related tests : Includes hepatitis C、syphilis and
 AIDS;

 -  Participated in any drug or medical device clinical trial within 1 month prior to the
 trial.