Preoperative Prediction of Lymph Node Metastasis in T1N0M0 Papillary Thyroid Carcinoma by Using Contrast-enhanced Ultrasound

NCT07357571 · tracked via the Priya Life Science China tracker

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Phase

Observational

Started

2025-12-01

Last updated

2026-01-22

Condition(s) studied

Thyroid Papillary CarcinomaContrast Enhanced Ultrasound

Study summary

Similarly, the burden of central lymph node metastasis affects the individualized management of patients with T1N0M0 papillary thyroid carcinoma (PTC): lymph node metastasis is a contraindication to thermal ablation; low-burden lymph node metastasis is suitable for lobectomy; and high-burden lymph node metastasis recommends total thyroidectomy. However, conventional preoperative imaging examinations have low efficacy in diagnosing central lymph node metastasis. This multicenter retrospective cross-sectional study enrolled 600 patients with T1N0M0 PTC who were admitted to our hospital from June 2018 to June 2025 and confirmed by postoperative pathology. Dynamic contrast-enhanced ultrasound (CEUS) images of the thyroid and lymph nodes before surgery were collected for all patients. Two senior ultrasound physicians unaware of the pathological results independently analyzed the images and extracted qualitative and quantitative CEUS features of lesions and suspicious lymph nodes. Taking postoperative pathological results as the gold standard, patients were divided into the high-burden metastasis group, low-burden metastasis group, and non-metastasis group. Univariate and multivariate Logistic regression analyses were used to screen independent predictors, construct a combined predictive model, and draw receiver operating characteristic (ROC) curves and decision curves to evaluate its diagnostic efficacy and clinical practicality. The primary outcome measure was the area under the curve (AUC), and the secondary outcome measures included sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and net benefit. This project is expected to achieve accurate preoperative prediction of the burden of central lymph node metastasis and realize precise and individualized treatment for patients with T1N0M0 PTC.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Invasiveness — 2018-2025
The burden of central lymph node metastasis. According to NCCN guidelines, The burden of central lymph node metastas is categorized as "high" (≥5 involved nodes or any metastatic focus ≥2 mm), "low" (\<5 involved nodes and all metastatic foci \<2 mm), and "none" (no central lymph node metastasis).

Trial sites (2)

Facility	City	Region	Status
Sun Yat-sen Memorial Hospital	Guangdong	Guangzhou	Recruiting
No. 33 Yingfeng Road, Haizhu District, Guangzhou City, Guangdong Province, Sun Yat-sen Memorial Hospital	Guangzhou	Guangzhou	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07357571 on ClinicalTrials.gov ↗ ← All trials in China