Skip to content

Randomized controlled clinical study of rhTSH aided iodine-131 treatment of nontoxic goiter

Randomized controlled clinical study of rhTSH aided iodine-131 treatment of nontoxic goiter

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096080
Enrollment
Unknown
Registered
2025-01-17
Start date
2025-01-30
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

goiter

Interventions

experiment group:rhTSH 0.1mg/ml hip muscle im 24 hour before radioiodine treatment
Control group:1ml 0.9% saline hip muscle im 24 hour before radioiodine treatment

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Meet the above diagnostic criteria; 2. Age >18 years old, male and female sex is not limited; 3. Thyroid volume 28ml-140ml(ultrasound), with or without benign nodules, and thyroid compression related symptoms or cosmetic needs, or both; 4. Normal TSH level or subclinical hyperthyroidism (i.e. serum TSH < 0.38 mU/L, serum T4 and T3 levels are normal); 5. Have contraindications for surgery or refuse surgery.

Exclusion criteria

Exclusion criteria: 1. Under 18 years of age; 2. Use of amiodarone or iodized contrast agents in the 12 months prior to enrollment; 3. Patients who do not want to participate in the study or do not want to sign informed consent; 4. Critically ill patients, suffering from mental diseases, can not cooperate with the examination of patients; 5. Pregnant and lactating women; 6. Severe heart diseases such as heart obstruction, heart failure, ventricular arrhythmia, and unstable angina pectoris within 3 months; 7. Severely impaired liver function (AST or ALT> 4 times the upper limit of normal); 8. Renal insufficiency (BUN or CR> 2 times the upper limit of normal); 9. The goiter has been treated with surgery or radioactive iodine; 10. Thyroid nodules indicate malignancy that cannot be confirmed by FNA cytology; 11. The volume of retrosternal goiter is 100 mL; 12. 24-hour thyroid absorption rate <20%.

Design outcomes

Primary

MeasureTime frame
Thyroid volume reduction rate;Goiter related quality of life;

Secondary

MeasureTime frame
Hypothyroid;

Countries

China

Contacts

Public ContactMa Chao

Shanghai the Tenth people's hospital

ponymachao@163.com+86 187 2128 8964

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026