Boosting thyroid cancer therapy: does rhTSH make radioactive iodine more effective?
NCT ID NCT04447183
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.
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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
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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
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Anyone
- Healthy volunteers
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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 Hide 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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