Treatment Efficacy and Safety of Low-dose Radioiodine Ablation for Intermediate-risk Differentiated Thyroid Carcinoma

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective: The 3-years disease-free survival was compared between low-dose group (30 mCi) and high-dose group (100 mCi).

Secondary objective: The successful remnant ablation, efficacy, 3-year progression-free survival and safety were compared between low-dose group (30 mCi) and high-dose group (100 mCi).

Research Hypothesis：The 3-year disease-free survival of low-dose group (30mci) may not be lower than that of high-dose group (100 mci) in intermediate-risk thyroid papillary carcinoma patients with no structural or functional lesions and stimulated thyroglobulin(ps-Tg)1-20ng/ml.

Study design：Single-center, randomized, double-blinded Sample size：254 patients Follow-up：The measurement of serum thyroid function, thyroglobulin/ anti-thyroglobulin antibody(Tg/TgAb) and neck ultrasonography were performed every 3-12 months during the 3 years according to patients' condition, and computerized tomography(CT) scan, positron emission tomography/computed tomography(PET/CT) and diagnostic whole-body 131I scan were added if necessary. Intervention：Randomly allocated into two groups to receive either 30 mCi (low-dose group) or 100 mCi (high-dose group ) radioiodine for post-thyroidectomy ablation therapy.

Evaluation index：Primary evaluation index: The 3-year disease-free survival. Secondary evaluation index: Successful remnant ablation, efficacy, the 3-year progression-free survival and safety.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Zhujiang Hospital

Criteria

Inclusion Criteria:

• Patients with histological confirmation of intermediate-risk papillary thyroid carcinoma(PTC) according to 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer.

• Differentiated Thyroid Carcinoma(DTC) patients who underwent total or near-total thyroidectomy which was consistent with the recommendations of American Thyroid Association guidelines as well as Chinese Thyroid Association guidelines on the management of Differentiated Thyroid Carcinoma(DTC).

• Serum stimulated thyroglobulin was 1-20ng/ml.

• At least 16 years old.

• Patients who volunteered to participate in the study and signed informed consent.

Exclusion Criteria:

• Ultrasonography, Computerized Tomography(CT), Magnetic Resonance Imaging(MRI) or Positron Emission Tomography/computed tomography (PET/CT) indicates the presence of lesions.

• Iodine-131 whole body scan indicates the presence of lesions outside the thyroid bed.

• Patients with positive thyroglobulin antibody (≥115 Ku/L).

• Patients who had other coexisting serious diseases or other factors that may affect the outcome of ablation.

• Pregnant or breastfeeding women, or with birth planning within six months.