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

Zelgen Biopharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Differentiated Thyroid Cancer

Treatments: Biological: rhTSH

Study type: Interventional

Funder types: Industry

Identifiers

NCT04971473

ZGTSH004

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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201 participants in 1 patient group

rhTSH+Thyroid hormone withdrawal

Experimental group

Description:

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.

Treatment:

Biological: rhTSH