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Search / Trial NCT04354324

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

Launched by ZHUJIANG HOSPITAL · Apr 16, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Radioactive Iodine Papillary Thyroid Carcinoma

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of two different doses of radioiodine treatment for patients with intermediate-risk papillary thyroid cancer, a common type of thyroid cancer. Specifically, the trial compares a low dose of 30 millicuries (mCi) to a higher dose of 100 mCi to see if the lower dose is just as effective in preventing cancer from returning over a period of three years. The trial aims to find out not only how many patients remain cancer-free, but also how well the treatment works overall and whether there are any safety concerns.

To be eligible for this study, participants must be at least 16 years old and have been diagnosed with intermediate-risk papillary thyroid cancer confirmed by a medical professional. They should have had surgery to remove most or all of their thyroid and have specific test results indicating their cancer risk level. During the study, participants will receive either the low or high dose of radioiodine and will be monitored regularly with blood tests and imaging scans to check their health and how well the treatment is working. This trial is currently recruiting participants and aims to provide important information about the best treatment options for this type of cancer.

Gender

ALL

Eligibility 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.

About Zhujiang Hospital

Zhujiang Hospital, affiliated with the Southern Medical University in Guangzhou, China, is a leading clinical research institution dedicated to advancing medical science and improving patient care through rigorous clinical trials. With a strong commitment to ethical standards and patient safety, the hospital boasts a multidisciplinary team of experienced researchers and healthcare professionals. Its state-of-the-art facilities enable the execution of innovative studies across various therapeutic areas, contributing valuable insights to the global medical community. Zhujiang Hospital aims to foster collaboration with academic institutions, pharmaceutical companies, and regulatory bodies to ensure the successful development of new therapies and enhance treatment options for patients.

Locations

Guangzhou, Guangdong, China

Patients applied

0 patients applied

Trial Officials

Huijuan Feng, Master

Study Chair

Southern Medical University, China

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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