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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04971473

Enrollment

201

Registered

2021-07-21

Start date

2021-09-10

Completion date

2023-07-05

Last updated

2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Differentiated Thyroid Cancer

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.

Interventions

BIOLOGICALrhTSH

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026