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

Differentiated Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04971473
• Other study ID #: ZGTSH004
• Status: Completed
• Phase: Phase 3
• Start date: September 10, 2021
• Est. completion date: July 5, 2023

Study information

• Verified date: March 2023
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: July 5, 2023
• Est. primary completion date: July 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Differentiated Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of concordant scans	scan findings in agreement in a given patient using each preparation method	48 hours after the radioiodine administration