Status:
RECRUITING
Treatment Efficacy and Safety of Low-dose Radioiodine Ablation for Intermediate-risk Differentiated Thyroid Carcinoma
Lead Sponsor:
Zhujiang Hospital
Conditions:
Papillary Thyroid Cancer
Eligibility:
All Genders
16+ years
Phase:
NA
Brief 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...
Detailed Description
Intermediate risk papillary thyroid carcinoma(PTC) patients with no structural and functional lesions and stimulated thyroglobulin( s-Tg) 1-20ng/ml were randomly divided into low-dose group (30 mCi) a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT04354324
Start Date
April 20 2020
End Date
June 30 2024
Last Update
March 15 2024
Active Locations (1)
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1
Huijuan Feng
Guangzhou, Guangdong, China, 510282