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

Zelgen Biopharmaceuticals

Status and phase: Active, not recruiting; Phase 2

Conditions: Differentiated Thyroid Cancer

Treatments: Drug: Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH); Other: radioactive iodine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04447183

ZGTSH002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Test group

Experimental group

Description:

The test 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.

Treatment:

Other: radioactive iodine

Drug: Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH)

Control group

Experimental group

Description:

The control group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high,TSH≥30mU/L), and were given oral radioiodine.

Treatment:

Other: radioactive iodine