Safety and Efficacy of rhTSH Compared With Thyroid Hormone Withdrawal for Adjuntive Diagnostic in Patients With Differentiated Thyroid Cancer Who Have Previously Undergone Thyroidectomy

Overview

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.

Full Title of Study: “An Open, Single-arm, Self-controlled, Multi-center Phase Ⅲ Clinical Study to Evaluate the Safety and Efficacy of Recombinant Human Thryoid Stimulating Hormone(rhTSH)Compared With Thyroid Hormone Withdrawal for Adjunctive Diagnostic in Patients With Differentiated Thyroid Cancer Who Have Previously Undergone Thyroidectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2023

Interventions

  • Biological: rhTSH
    • Scanning was done 48 hours after the radioiodine administration. Each patient was scanned first following rhTSH and then scanned after thyroid hormone withdrawal.

Arms, Groups and Cohorts

  • Experimental: rhTSH+Thyroid hormone withdrawal
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • the rate of concordant scans
    • Time Frame: 48 hours after the radioiodine administration
    • scan findings in agreement in a given patient using each preparation method

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Suzhou Zelgen Biopharmaceuticals Co.,Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yansong Lin, Principal Investigator, Peking Union Medical College Hospital
  • Overall Contact(s)
    • Yansong Lin, PhD, +861069156114, linys@pumch.cn

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