Clinical trial · Interventional
rhTSH for Radioactive Iodine Remnant Ablation in Differentiated Thyroid Cancer
A Phase 2 Study to Evaluate the Safety and Efficacy of Recombinant Human Thyrotropin (rhTSH) for Radioactive Iodine (RAI) Remnant Ablation in Participants With Differentiated Thyroid Cancer (DTC)
NCT04447183CI-TRIAL-00125950completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized, open, parallel controlled, multi-center clinical trial; 120 subjects were randomly assigned to the test group and the control group according to 3:1.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Differentiated Thyroid Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radioactive iodine | Other | — | UNRESOLVED |
| Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Test group
- description
- The test 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 Thyrogen (0.9 mg daily on two consecutive days) followed by oral radioiodine.
- interventionNames
- Drug: Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH)
- Other: radioactive iodine
- type
- EXPERIMENTAL
- label
- Control group
- description
- The control group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high,TSH≥30mU/L), and were given oral radioiodine.
- interventionNames
- Other: radioactive iodine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.