Low-dose Radioiodine Treatment for Intermediate-risk Thyroid Cancer
Treatment Efficacy and Safety of Low-dose Radioiodine Ablation for Intermediate-risk Differentiated Thyroid Carcinoma Patients Without Metastasis: a Double-blind Randomized Clinical Trial
This study tests whether a lower dose of radioiodine treatment can help people with intermediate-risk thyroid cancer stay cancer-free for longer compared to a higher dose.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 254 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04354324 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of low-dose radioiodine ablation (30 mCi) compared to high-dose radioiodine ablation (100 mCi) in patients with intermediate-risk papillary thyroid carcinoma. The study is a single-center, randomized, double-blind trial involving 254 patients who have undergone total or near-total thyroidectomy. The primary objective is to compare the 3-year disease-free survival rates between the two groups, while secondary objectives include assessing successful remnant ablation, progression-free survival, and safety over a follow-up period of three years.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16 and older with histologically confirmed intermediate-risk papillary thyroid carcinoma and a stimulated thyroglobulin level of 1-20 ng/ml.
Not a fit: Patients with structural or functional lesions detected by imaging studies will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and equally effective alternative to high-dose radioiodine therapy for patients with intermediate-risk thyroid cancer.
How similar studies have performed: Other studies have shown promising results with low-dose radioiodine therapy, suggesting that this approach may be effective, although this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Huijuan Feng — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Huijuan Feng, Master
- Email: fhj0406@126.com
- Phone: 86-13798181698
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.