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Dose study of 131I adjuvant therapy after DTC surgery

Dose study of 131I adjuvant therapy after DTC surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110781
Enrollment
Unknown
Registered
2025-10-20
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Differential thyroid cancer after surgery

Interventions

Low-dose Iodine-131 treatment group (100 mCi):The adjuvant treatment dose of 131I is 100 mCi.
Medium-dose Iodine-131 treatment group (125 mCi):The adjuvant treatment dose of 131I is 125 mCi.
High-dose Iodine-131 treatment group (150 mCi):The adjuvant treatment dose of 131I is 150 mCi.

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The patient voluntarily participated in this study and signed the informed consent form; 2. Age range: 18 - 70 years old; 3. Patients who underwent total thyroidectomy due to DTC and are planning to receive iodine-131 "adjuvant therapy" for the first time; 4. Recurrence risk category: medium, high, and/or ps-Tg > 10 µg/L; 5. No clear (remnants) or metastasis was observed in traditional imaging [ultrasound (neck), CT (including neck, chest, abdomen), whole-body bone imaging, and thyroid imaging]; salivary gland imaging evaluated normal salivary gland function; 6. There were no significant abnormalities in the main organ functions that affected this treatment; 7. The patient had no obvious physical discomfort before iodine treatment; 8. For fertile women (such as those who have not undergone surgical sterilization or those who have not reached menopause for less than one year), the blood pregnancy test was negative, and they must be non-lactating patients; fertile men and women agreed to take effective contraceptive measures from signing the informed consent form until the end of the study, and were not allowed to donate sperm or eggs.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will not be included in this study: 1. Do not meet the "adjuvant therapy" criteria defined in this study; 2. Lack of general information and/or clinical data such as thyroid function, ultrasound, CT, etc.; 3. After iodine-131 treatment, the patient did not undergo regular follow-up or the follow-up items were incomplete (including thyroid function, neck ultrasound, neck, chest, abdominal CT, whole-body bone imaging, Dx-WBS examination, and salivary gland imaging), and it is impossible to conduct efficacy assessment according to the "Initial Treatment Response Evaluation System" in the ATA and Chinese Medical Association guidelines; 4. Important organ function failure, unable to tolerate treatment; 5. The patient is obviously physically uncomfortable and unable to tolerate iodine-131 treatment.

Design outcomes

Primary

MeasureTime frame
The ER rate of the treatment;

Secondary

MeasureTime frame
Radiation Absorption Dose Characteristics;The condition of salivary gland function;

Countries

China

Contacts

Public ContactDai Dong

Tianjin Medical University Cancer Institute and Hospital

xiandao5502@163.com+86 186 2200 0577

Outcome results

None listed

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