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The relationship between initial 131I therapy and clinical outcomes in patients with non-metastatic and high-risk differentiated thyroid cancer with postoperative low thyroglobulin levels (Tg=5ng/ml) : a prospective, open, randomized controlled clinical study

The relationship between initial 131I therapy and clinical outcomes in patients with non-metastatic and high-risk differentiated thyroid cancer with postoperative low thyroglobulin levels (Tg=5ng/ml) : a prospective, open, randomized controlled clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081902
Enrollment
Unknown
Registered
2024-03-14
Start date
2021-08-01
Completion date
Unknown
Last updated
2024-03-18

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

Conditions

Different thyroid cancer

Interventions

Group A:100mCi 131I
Group B:150mCi 131I

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Age=18 years old; (2) Complete total thyroidectomy, subtotal thyroidectomy or near-total thyroidectomy and cervical lymph node dissection; (3) Patients with differentiated thyroid carcinoma, including papillary carcinoma (PTC), follicular papillary carcinoma and follicular carcinoma (FTC); (4) Without the history of 131I treatment; (5) Less than 6 months between the completion of thyroid surgery and the initial 131I treatment ; (6) High-risk patients who meet one of the following criteria in the 2015 ATA guidelines; 1) Macroscopic treatment of perithyroid invasion (extensive extra-thyroid invasion); 2) Residual tumor; 3) The pathological stage was N1, with the maximum diameter of any lymph node =3cm; 4) Extensive vascular invasion of FTC (>4 lesions) (7) Thyroglobulin (s-Tg) level in stimulated state = 5ng/ml; (8) ECOG physical status 0 or 1 score.

Exclusion criteria

Exclusion criteria: (1) Partial thyroidectomy; (2) The histological types were medullary thyroid carcinoma, undifferentiated carcinoma, Hurtle cells, aggressive histological types (high cells, shoe spikes or columnar cells); (3) Patients with distant metastasis at first diagnosis (M1); (4) Thyroglobulin (s-Tg) level > 5ng/ml under stimulation; (5) Patients with incomplete surgical and postoperative pathological data could not accurately stratify risk; (6) Patients with other malignant tumors or a history of malignant tumors; (7) Have a history of serious heart, liver, lung, kidney dysfunction and other systemic multiple organ system function impairment; (8) Pregnant patients (regardless of gender), pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
RFS;

Secondary

MeasureTime frame
Thyroglobulin;

Countries

China

Contacts

Public ContactLin Li

West China Hospital of Sichuan University

lilinhuaxi@sina.com+86 189 8060 1584

Outcome results

None listed

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