Thyroid cancer
Conditions
Interventions
Experimental group:Injection rhTSH
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. At the time of signing informed consent, the age is 18-75 years old (including the boundary value), and the gender is not limited; 2. Those who have the capacity to act, and voluntarily participate in this clinical study, and sign the informed consent form; 3. Patients with differentiated thyroid cancer (DTC) diagnosed with no distant metastasis after pathological diagnosis; 4. Have undergone total thyroidectomy or near-total thyroidectomy, and the time before surgery >=4 weeks; 5. Proposed first 131I nail removal or adjuvant therapy. Indications for nail removal treatment: (1) Patients with an intermediate risk of recurrence; (2) Low-risk patients who are convenient for long-term follow-up and tumor recurrence monitoring, and who are willing to do so; (3) After most thyroidectomy, patients who have the clinical need for supplementary total resection and are unwilling or unsuitable for reoperation after postoperative evaluation; (4) Patients with 131I concentration in DxWBS only thyroid bed, TgAb negative and sTgPatients with 1.0 ng/mL are also indicated for patients with high serum Tg levels or persistently elevated TgAbs.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating female patients; 2. Those who plan to become pregnant within 6 months; 3. Those whose surgical incisions are not completely healed; 4. Those who are allergic to the experimental drug (rhTSH or 131I) or its excipients; 5. Patients who are unable to comply with radiological protection requirements; 6. Those who are considered unsuitable by the investigator to participate in this clinical study; 7. Those with an expected survival period of less than 6 months; 8. Patients with inhibitory Tg > 10ng/mL under normal TSH suppression therapy; 9. Patients with high clinical suspicion or clinical evidence suggesting that DTC has metastasized.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety to toleration;Dynamic assessment of efficacy; | — |
Countries
China
Contacts
Public ContactWei Zheng
Tianjin Medical University General Hospital
Outcome results
None listed