rhTSH for Radioactive Iodine Remnant Ablation in Participants With Differentiated Thyroid Cancer (DTC)

This study was conducted in patients with differentiated thyroid cancer who had undergone total/near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation. One group of patients who took thyroid hormone medicine and were euthyroid [i.e. their thyroid stimulating hormone (TSH) levels are normal], and received injections of rhTSH (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high), and were given oral radioiodine.

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Key information

Conditions

Differentiated Thyroid Cancer

Age range

18 year and older

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 years old, either male or female.
Patients with diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant, characterized as pT 1-3, N 0-1or Nx, and M0.
Eastern Cooperative Oncology Group (ECOG) score of 0-2;
Expected life expectancy is greater than 12 weeks;
Patients with a total or near-total thyroidectomy within 12 months prior to randomized.
Low iodine diet for two weeks prior to randomized.

Exclusion criteria

patients with recent history of 131I whole body scan within 2 weeks prior to randomized.
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

rhTSH (0.9 mg) was administered intramuscularly (IM) once daily (qd) for 2 days. Twenty-four hours following the second dose of rhTSH

Other names: Recombinant human thyroid-stimulating hormone

Radioiodine (131I)

Radiation

Patients were given an ablative dose of 131I (30 mCi±1.5 mCi).

Primary outcomes

The rate of successful postoperative thyroid ablation

Time frame: 8 months later by a rhTSH stimulated radioiodine scan

Patients were considered successfully ablated if there was no visible thyroid bed uptake on the scan

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

A Phase 3, Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy and Safety of Recombinant Human Thyrotropin (rhTSH) for Radioactive Iodine (RAI) Remnant Ablation in Postoperative Participants With Differentiated Thyroid Cancer (DTC)

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2026
First posted: Jul 16, 2021
Registry last updated: Sep 8, 2026

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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Completed