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

Phase 3

Completed

• Conditions: Differentiated Thyroid Cancer

• Registration Number: NCT04971473
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-21
• Study Start: 2021-09-10
• Status Verified: 2023-03
• Primary Completion: 2023-07-05
• Study Completion: 2023-07-05
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China