Back to resultsComparison 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
Primary Purpose
Differentiated Thyroid Cancer
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
rhTSH
Sponsored by
About this trial
This is an interventional treatment trial for Differentiated Thyroid Cancer
Eligibility Criteria
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.
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rhTSH+Thyroid hormone withdrawal
Arm 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.
Outcomes
Primary Outcome Measures
the rate of concordant scans
scan findings in agreement in a given patient using each preparation method
Secondary Outcome Measures
Full Information
NCT ID
NCT04971473
First Posted
July 7, 2021
Last Updated
March 22, 2023
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04971473
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Differentiated Thyroid Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
201 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rhTSH+Thyroid hormone withdrawal
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
rhTSH
Other Intervention Name(s)
recombinant human thyroid stimulating hormone
Intervention Description
Scanning was done 48 hours after the radioiodine administration. Each patient was scanned first following rhTSH and then scanned after thyroid hormone withdrawal.
Primary Outcome Measure Information:
Title
the rate of concordant scans
Description
scan findings in agreement in a given patient using each preparation method
Time Frame
48 hours after the radioiodine administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yansong Lin, PhD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Learn more about this trial
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
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