Boosting thyroid cancer therapy: does rhTSH make radioactive iodine more effective?

NCT ID NCT04447183

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This phase 2 trial tests whether giving recombinant human thyroid stimulating hormone (rhTSH) before radioactive iodine can improve the destruction of leftover thyroid tissue after surgery in people with differentiated thyroid cancer. Participants receive either rhTSH injections plus radioactive iodine or radioactive iodine alone. The study measures how often the ablation succeeds, based on scans and blood tests, and tracks side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Recombinant human thyroid stimulating hormone (rhTSH) given as injections before radioactive iodine therapy
What this could lead to
If it works, rhTSH could make radioactive iodine ablation more effective and safer, potentially reducing the need for thyroid hormone withdrawal and improving outcomes for people with differentiated thyroid cancer.
What could go wrong
This is a phase 2 trial with a modest number of participants, so results may not hold up in larger studies. The treatment could also cause side effects or fail to improve ablation success rates compared to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

123 people

The number who actually took part.

Started

Nov 2020

Finished

May 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pathological diagnosis of differentiated thyroid cancer, including papillary thyroid cancer (including papillary carcinoma follicular subtype), follicular thyroid cancer, and Hurthle cell thyroid cancer; * Patients who were at 18\~75 years old (male or female). * Patients with a total or near-total thyroidectomy within 12 weeks prior to enrollment and plan to performing radioactive iodine((131)Ⅰ) thyroid remnant ablation. * Serum TSH ≤ 0.5 mU/L; * Women of childbearing age are HCG-negative; * Low iodine diet before enrollment for more than 4 weeks; * Patients are voluntarily enrolled, and written informed consent forms can be used for treatment and visits as required by the program. Exclusion Criteria: * Any significant clinical and laboratory abnormalities (eg, severe cardiopulmonary disease, hepatic insufficiency, renal function Incomplete, congestive heart failure, advanced lung disease or advanced cardiovascular and cerebrovascular disease, active infection); * Patients who have used any water-soluble radiographic contrast agent intravenously, underwent intrathecal iodine angiography or gallbladder iodine imaging within 3 months before administration; * Taken/eaten within 4 weeks prior to administration Drugs/foods that affect iodine uptake or metabolism, such as multivitamins, glucocorticoids, diuretics, lithium, thiouracil, tazobactam, algae, iodine (except thyroid hormone replacement therapy); * Before administration Stroke, unstable angina (CCS class II or higher), atrial fibrillation or medication (within beta blocker or digoxin) within 6 months Patients with a history of arrhythmia; * Pregnant or lactating women; * Patients who are allergic to rhTSH and its excipients; * Patients with positive infection-related tests : Includes hepatitis C、syphilis and AIDS; * Participated in any drug or medical device clinical trial within 1 month prior to the trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

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