Comparison of the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal

Study Overview
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Brief Summary
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This is A non-blinded trial. Oral radioiodine was given 24 hours after the second injection of rhTSH, and scanning was done 48 hours after the radioiodine administration. Each patient was scanned first following rhTSH and then scanned after thyroid hormone withdrawal.

Official Title
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An Open, Single-arm, Self-controlled, Multi-center Phase 3 Study to Compare the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal

Conditions
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Differentiated Thyroid Cancer

Intervention / Treatment
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* Biological: rhTSH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects voluntarily sign the informed consent form (ICF). Age 18-75 years old, either male or female. Patients with diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant,. Patients with a total or near-total thyroidectomy within 6 weeks prior to administered. Low iodine diet for 4 weeks prior to randomized. Exclusion Criteria: Pregnant or breast feeding women. Patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission) Subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator. Subjects who have participated in another clinical trial of a new drug or medical instrument within 1 months before screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rhTSH+Thyroid hormone withdrawal<br>rhTSH: rhTSH(0.9 mg) was administered intramuscularly (IM) once daily (qd) for 2 days. Twenty-four hours following the second dose of rhTSH.Oral radioiodine was given 24 hours after the second injection of rhTSH, and scanning was done 48 hours after the radioiodine administration. Thyroid hormone withdrawal: Patients stop taking thyroid hormone for 14 days, and then monitor the level of thyroid stimulating hormone every week. When TSH>30mU/L, an ablative activity of 131I was administered.and scanning was done 48 hours after the radioiodine administration. | Biological: rhTSH<br>* Scanning was done 48 hours after the radioiodine administration. Each patient was scanned first following rhTSH and then scanned after thyroid hormone withdrawal.<br>* Other names: recombinant human thyroid stimulating hormone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of concordant scans | scan findings in agreement in a given patient using each preparation method | 48 hours after the radioiodine administration |