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

NCT04971473 | Completed Phase 3

• 1 other identifier: ZGTSH004
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Differentiated Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• the rate of concordant scans

  scan findings in agreement in a given patient using each preparation method

  48 hours after the radioiodine administration

Study Arms (1)

rhTSH+Thyroid hormone withdrawal

EXPERIMENTAL

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

Interventions

rhTSH BIOLOGICAL

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

Also known as: recombinant human thyroid stimulating hormone

rhTSH+Thyroid hormone withdrawal

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

• Lin Y, Wen Q, Fu W, Yang H, Gao Y, Li Z, Huang J, Gao Z, Wu J, Lv Z, Lu K, Chen Y, Yang A, OuYang W, Zhang S, Zhou H, Deng Z, Chen Z, Ding Y, Yuan C, Li L, Lin C, Sang S, Cheng Z, Cheng Y. RhTSH in aiding dynamic assessment in patients with differentiated thyroid Cancer. Eur J Nucl Med Mol Imaging. 2025 Dec;53(1):389-397. doi: 10.1007/s00259-025-07349-1. Epub 2025 Jun 9.

  PMID: 40488858 DERIVED

MeSH Terms

Interventions

Thyrotropin Alfa

Intervention Hierarchy (Ancestors)

Thyrotropin; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Yansong Lin, PhD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 21, 2021
• Study Start: September 10, 2021
• Primary Completion: July 5, 2023
• Study Completion: July 5, 2023
• Last Updated: March 28, 2024

Record last verified: 2023-03

Locations

CN (1)