Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Completed NCT04447183

rhTSH for Radioactive Iodine Remnant Ablation in Differentiated Thyroid Cancer

Conditions: Differentiated Thyroid Cancer

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 123
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Location: Peking Union Medical College Hospital Beijing Beijing Municipality

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04447183). StuddyBuddy aggregates publicly available trial information.