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Completed

NCT Number: NCT04971473

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

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.

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Key information

Conditions

Differentiated Thyroid Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: recombinant human thyroid stimulating hormone

Primary outcomes

  1. the rate of concordant scans

    Time frame: 48 hours after the radioiodine administration

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

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 21, 2021
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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