Using contrast-enhanced ultrasound to predict lymph node spread in small papillary thyroid cancer
Multicenter Retrospective Study of Dual-mode Contrast-enhanced Ultrasound Predictive Model for Lymph Node Metastasis Burden in T1N0M0 Papillary Thyroid Carcinoma
This will test whether contrast-enhanced ultrasound can predict lymph node spread before surgery in people with small (T1N0M0) papillary thyroid cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Guangdong, Guangzhou and 1 other locations) |
| Trial ID | NCT07357571 on ClinicalTrials.gov |
What this trial studies
Central lymph node metastasis (CLNM) changes surgical decisions for patients with T1N0M0 papillary thyroid carcinoma, but conventional preoperative imaging often misses CLNM. This multicenter retrospective cross-sectional study enrolled 600 patients treated between June 2018 and June 2025 whose diagnoses were confirmed by postoperative pathology. Preoperative dynamic contrast-enhanced ultrasound (CEUS) images of the thyroid and suspicious central nodes were collected and two senior ultrasound physicians blinded to pathology independently extracted qualitative and quantitative imaging features. Those imaging features will be compared to the surgical pathology gold standard to build and validate preoperative prediction models for CLNM.
Who should consider this trial
Good fit: Patients with T1N0M0 papillary thyroid carcinoma (tumor ≤2 cm) who had preoperative conventional ultrasound and CEUS and who proceeded to initial thyroid surgery with central lymph node dissection are the ideal candidates.
Not a fit: Patients who received prior anti-tumor treatment, have poor-quality or missing preoperative imaging, have larger tumors, non-papillary thyroid cancers, distant metastases, or prior neck surgery are unlikely to benefit from this prediction approach.
Why it matters
Potential benefit: If successful, this approach could enable more accurate preoperative detection of central lymph node metastasis and help doctors choose the least invasive, safest surgery for each patient.
How similar studies have performed: Prior single-center and smaller studies using ultrasound and CEUS features have shown promising results for predicting lymph node metastasis, but large multicenter validation remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Patients with preoperative assessment of T1N0M0 papillary thyroid carcinoma who underwent initial surgical treatment at the medical centers participating in this study between June 2018 and June 2025. 2. Definitive diagnosis of papillary thyroid carcinoma confirmed by postoperative histopathological examination. 3. Preoperative conventional ultrasound and contrast-enhanced ultrasound (CEUS) examination of the thyroid and/or suspicious central lymph nodes were performed, with complete imaging data of acceptable quality for analysis. 4. Surgical procedures included thyroidectomy (lobectomy or total thyroidectomy) combined with central lymph node dissection (prophylactic or therapeutic) to provide a definitive pathological gold standard for lymph nodes. 5. Complete clinical pathological data and imaging data were retrievable from the Hospital Information System (HIS). Exclusion Criteria 1. Preoperative receipt of any anti-tumor treatment targeting the thyroid (e.g., radiotherapy, chemotherapy, targeted therapy, or ablation therapy). 2. Complication with other types of thyroid malignant tumors (e.g., medullary carcinoma, undifferentiated carcinoma, etc.). 3. History of neck surgery or radiotherapy that may affect the structure of cervical lymph nodes. 4. Complication with other systemic diseases that may affect CEUS perfusion characteristics or imaging evaluation (e.g., severe heart failure, liver cirrhosis, etc.). 5. Allergy to components of the ultrasound contrast agent. 6. Missing key clinical or imaging data, making complete analysis impossible.
Where this trial is running
Guangdong, Guangzhou and 1 other locations
- Sun Yat-sen Memorial Hospital — Guangdong, Guangzhou, China (Recruiting)
- No. 33 Yingfeng Road, Haizhu District, Guangzhou City, Guangdong Province, Sun Yat-sen Memorial Hospital — Guangzhou, Guangzhou, China (Recruiting)
Study contacts
- Principal investigator: Jingliang Ruan, Doctoral Degree — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: Jingliang Ruan, Doctoral Degree
- Email: ruanjl3@mail.sysu.edu.cn
- Phone: +86-13694202230
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.