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
NCT ID: NCT04971473
Last Updated: 2024-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
201 participants
INTERVENTIONAL
2021-09-10
2023-07-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
rhTSH
Scanning was done 48 hours after the radioiodine administration. Each patient was scanned first following rhTSH and then scanned after thyroid hormone withdrawal.
Interventions
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rhTSH
Scanning was done 48 hours after the radioiodine administration. Each patient was scanned first following rhTSH and then scanned after thyroid hormone withdrawal.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Suzhou Zelgen Biopharmaceuticals Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Yansong Lin, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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References
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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 Jun 9. doi: 10.1007/s00259-025-07349-1. Online ahead of print.
Other Identifiers
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ZGTSH004
Identifier Type: -
Identifier Source: org_study_id
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