Preoperative Prediction of Lymph Node Metastasis in T1N0M0 Papillary Thyroid Carcinoma by Using Contrast-enhanced Ultrasound
Multicenter Retrospective Study of Dual-mode Contrast-enhanced Ultrasound Predictive Model for Lymph Node Metastasis Burden in T1N0M0 Papillary Thyroid Carcinoma
1 other identifier
observational
600
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2025
CompletedFirst Submitted
Initial submission to the registry
December 18, 2025
CompletedFirst Posted
Study publicly available on registry
January 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
January 22, 2026
January 1, 2026
1.1 years
December 18, 2025
January 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Invasiveness
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).
2018-2025
Study Arms (2)
High Metastasis Burden Group
≥5 involved lymph nodes or the maximum diameter of any involved lymph node ≥2 mm
Low Metastasis Burden Group
\<5 involved lymph nodes and the maximum diameter of all involved lymph nodes \<2 mm.
Eligibility Criteria
Patients with T1N0M0 papillary thyroid carcinoma (PTC) who underwent initial surgical treatment and had preoperative evaluation confirmed as T1N0M0 at the medical centers participating in this study between June 2018 and June 2025.
You may qualify if:
- 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.
- Definitive diagnosis of papillary thyroid carcinoma confirmed by postoperative histopathological examination.
- 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.
- 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.
- Complete clinical pathological data and imaging data were retrievable from the Hospital Information System (HIS).
You may not qualify if:
- Preoperative receipt of any anti-tumor treatment targeting the thyroid (e.g., radiotherapy, chemotherapy, targeted therapy, or ablation therapy).
- Complication with other types of thyroid malignant tumors (e.g., medullary carcinoma, undifferentiated carcinoma, etc.).
- History of neck surgery or radiotherapy that may affect the structure of cervical lymph nodes.
- Complication with other systemic diseases that may affect CEUS perfusion characteristics or imaging evaluation (e.g., severe heart failure, liver cirrhosis, etc.).
- Allergy to components of the ultrasound contrast agent.
- Missing key clinical or imaging data, making complete analysis impossible.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sun Yat-sen Memorial Hospital
Guangdong, Guangzhou, 510000, China
No. 33 Yingfeng Road, Haizhu District, Guangzhou City, Guangdong Province, Sun Yat-sen Memorial Hospital
Guangzhou, Guangzhou, 510288, China
Related Publications (11)
Riley RD, Ensor J, Snell KIE, Harrell FE Jr, Martin GP, Reitsma JB, Moons KGM, Collins G, van Smeden M. Calculating the sample size required for developing a clinical prediction model. BMJ. 2020 Mar 18;368:m441. doi: 10.1136/bmj.m441. No abstract available.
PMID: 32188600BACKGROUNDRiley RD, Collins GS, Ensor J, Archer L, Booth S, Mozumder SI, Rutherford MJ, van Smeden M, Lambert PC, Snell KIE. Minimum sample size calculations for external validation of a clinical prediction model with a time-to-event outcome. Stat Med. 2022 Mar 30;41(7):1280-1295. doi: 10.1002/sim.9275. Epub 2021 Dec 16.
PMID: 34915593BACKGROUNDLuo ZY, Hong YR, Yan CX, Wang Y, Ye Q, Huang P. Utility of quantitative contrast-enhanced ultrasound for the prediction of lymph node metastasis in patients with papillary thyroid carcinoma. Clin Hemorheol Microcirc. 2022;80(1):37-48. doi: 10.3233/CH-200909.
PMID: 33252064BACKGROUNDYu Y, Shi LL, Zhang HW, Wang Q. Performance of contrast-enhanced ultrasound for lymph node metastasis in papillary thyroid carcinoma: a meta-analysis. Endocr Connect. 2023 Jan 19;12(2):e220341. doi: 10.1530/EC-22-0341. Print 2023 Feb 1.
PMID: 36524799BACKGROUNDLi QL, Ma T, Wang ZJ, Huang L, Liu W, Chen M, Sang T, Ren XG, Tong J, Cao CL, Dong J, Li J. The value of contrast-enhanced ultrasound for the diagnosis of metastatic cervical lymph nodes of papillary thyroid carcinoma: A systematic review and meta-analysis. J Clin Ultrasound. 2022 Jan;50(1):60-69. doi: 10.1002/jcu.23073. Epub 2021 Oct 8.
PMID: 34625988BACKGROUNDYang Z, Wang X, Tao T, Zou J, Qiu Z, Wang L, Du H, Chen N, Yin X. Diagnostic value of contrast-enhanced ultrasonography in the preoperative evaluation of lymph node metastasis in papillary thyroid carcinoma: a single-center retrospective study. BMC Surg. 2023 Oct 24;23(1):325. doi: 10.1186/s12893-023-02199-w.
PMID: 37875825BACKGROUNDChen L, Chen L, Liang Z, Shao Y, Sun X, Liu J. Value of Contrast-Enhanced Ultrasound in the Preoperative Evaluation of Papillary Thyroid Carcinoma Invasiveness. Front Oncol. 2022 Jan 14;11:795302. doi: 10.3389/fonc.2021.795302. eCollection 2021.
PMID: 35096595BACKGROUNDHong YR, Luo ZY, Mo GQ, Wang P, Ye Q, Huang PT. Role of Contrast-Enhanced Ultrasound in the Pre-operative Diagnosis of Cervical Lymph Node Metastasis in Patients with Papillary Thyroid Carcinoma. Ultrasound Med Biol. 2017 Nov;43(11):2567-2575. doi: 10.1016/j.ultrasmedbio.2017.07.010. Epub 2017 Aug 12.
PMID: 28807450BACKGROUNDYang J, Zhang F, Qiao Y. Diagnostic accuracy of ultrasound, CT and their combination in detecting cervical lymph node metastasis in patients with papillary thyroid cancer: a systematic review and meta-analysis. BMJ Open. 2022 Jul 4;12(7):e051568. doi: 10.1136/bmjopen-2021-051568.
PMID: 35788082BACKGROUNDZhao F, Wang P, Yu C, Song X, Wang H, Fang J, Zhu C, Li Y. A LASSO-based model to predict central lymph node metastasis in preoperative patients with cN0 papillary thyroid cancer. Front Oncol. 2023 Jan 25;13:1034047. doi: 10.3389/fonc.2023.1034047. eCollection 2023.
PMID: 36761950BACKGROUNDZheng WH, Li C, Sun RH, Shui CY, Wang X, He TQ, Cai YC, Ning YD, Jiang J, Qin G, Zhou YQ, Liu W. [Advances in the research of central lymph node dissection for cN0 thyroid papillary carcinoma]. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2020 Aug 7;55(8):799-803. doi: 10.3760/cma.j.cn115330-20200411-00289. Chinese.
PMID: 32791784BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jingliang Ruan, Doctoral Degree
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Chief Physician
Study Record Dates
First Submitted
December 18, 2025
First Posted
January 22, 2026
Study Start
December 1, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
January 22, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 2025-2026
- Access Criteria
- Eligible academic researchers (with ethics committee approval for thyroid cancer imaging-related studies) may access the de-identified IPD (including dual-modality ultrasound data, clinical baseline records, and postoperative pathology results of thyroid carcinoma patients). To request access, researchers need to submit a formal application to the study leading team (via email) detailing their research purpose; after review and approval, they will receive access credentials for the study's encrypted secure data-sharing platform.
1. Preoperative dual-modality ultrasound files/reports (conventional/CEUS features of lesions/central lymph nodes); 2. Clinical baseline data (age, gender, pathology subtype, TNM stage, thyroid function); 3. Postoperative pathology data (metastatic central lymph node count, focus diameter). All data are anonymized (no personal info) to protect privacy. Eligible researchers (with ethics approval for thyroid cancer studies) may apply via the study's encrypted platform 12 months post-study completion. IPD is for non-commercial academic use only.