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A Prospective Controlled Study on the Efficacy and Safety of Recombinant Human Thyrotropin Injection (rh-TSH) in Postoperative Patients with Differentiated Thyroid Carcinoma (DTC) for Sequential 131I Thyroid Ablation/Metastasis Ablation Therapy Guided by Low-Dose 131I SPECT/CT Precise Evaluation

A Prospective Controlled Study on the Efficacy and Safety of Recombinant Human Thyrotropin Injection (rh-TSH) in Postoperative Patients with Differentiated Thyroid Carcinoma (DTC) for Sequential 131I Thyroid Ablation/Metastasis Ablation Therapy Guided by Low-Dose 131I SPECT/CT Precise Evaluation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110577
Enrollment
Unknown
Registered
2025-10-16
Start date
2025-10-16
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Differentiated Thyroid Carcinoma

Interventions

rh-TSH Group:Administration of two doses of rh-TSH (24 hours apart)
Control group:Iodine-131 therapy based on the conventional withdrawal method (THW)

Sponsors

The Sixth Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 75 years old; (2) Patients diagnosed with differentiated thyroid carcinoma (DTC) confirmed by pathological diagnosis; (3) Patients who have undergone total or near-total thyroidectomy; (4) Imaging examinations indicate the presence of residual lesions; (5) Patients with capacity for conduct, who voluntarily participate in this clinical study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients allergic to the investigational drugs (rh-TSH or 131I) or their excipients; (2) Women of childbearing age with positive serum HCG; (3) Patients unable to comply with radiation protection requirements; (4) Patients with an expected survival time of less than 6 months; (5) Patients deemed unsuitable for participation in this clinical study by the investigator(s).

Design outcomes

Primary

MeasureTime frame
Thyroid-Stimulating Hormone,TSH;Thyroglobulin,Tg;Thyroglobulin Antibody,TgAb; Diagnostic Iodine Whole-Body Scan (Dx-WBS);Post-RAI WBS whole-body scan(Rx-WBS);—

Countries

China

Contacts

Public Contactzhanwen zhang

The Sixth Affiliated Hospital of Sun Yat-sen University (Financial City Campus)

zhzhanw7@mail.sysu.edu.cn+86 20 3828 5014

Outcome results

None listed

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