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Starting soon Observational

Multimodal Deep Learning for Lymph Node Metastasis in Thyroid Cancer

NCT07299318 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2026-01-01
Last updated
2025-12-23

Condition(s) studied

Papillary Thyroid Carcinoma

Investigational drug(s) / intervention(s)

not intervention

not intervention: This is a retrospective observational study in which participants will not undergo any interventions, and only data collection and analysis will be performed on the participants.

Study summary

Papillary thyroid carcinoma (PTC) is the most common endocrine malignancy in clinical practice, accounting for approximately 85% of all thyroid malignancies. The occurrence of cervical lymph node metastasis further increases the risk of local tumor recurrence and distant metastasis, thereby reducing patient survival rates. Pathological examinations reveal that approximately 30-80% of PTC patients have lymph node metastasis. Early detection of metastatic lymph nodes and the development of individualized treatment plans are crucial for improving patient prognosis. Currently, the primary method for diagnosing lymph node metastasis is ultrasound-guided fine-needle aspiration, but its accuracy is limited by sample quality and carries a risk of false-negative results. In recent years, deep learning technology has demonstrated significant potential in the field of medical image analysis. Therefore, the investigators aim to develop a deep learning model based on neck ultrasound to more accurately predict lymph node metastasis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: Cases aged 18-80 years who underwent thyroid ultrasound examination and postoperative pathological examination of the thyroid. Cases with a first-time diagnosis of papillary thyroid carcinoma. Cases who underwent lymph node dissection Exclusion Criteria: Cases aged \<18 years or \>80 years. Cases with poor-quality ultrasound images. Cases with incompletely visualized nodules. Cases with images showing multiple distinct lesions. Cases belonging to special populations. Cases with concurrent other tumors. Cases with a history of thyroid cancer resection

Primary outcome measure(s)

  • Area Under the Receiver Operating Characteristic Curve for a Multimodal Deep Learning Model Based on Cervical Ultrasound in Predicting Lymph Node Metastasis — Within 2 months after the completion of subject enrollment
    The researcher will employ a multimodal deep learning model that integrates preoperative cervical color Doppler ultrasound images with corresponding structured text reports. The final output of the model is a predicted probability of lymph node metastasis for each patient (a continuous value between 0 and 1). This predicted probability will be compared with postoperative histopathological diagnosis results (the gold standard). A receiver operating characteristic curve will be plotted for the model, and its area under the curve will be calculated.This is the gold standard metric for evaluating the discriminative ability of a binary classification model (metastasis vs. non-metastasis). A higher AUC value indicates stronger overall discriminative power of the model.
  • Sensitivity of a Multimodal Deep Learning Model Based on Cervical Ultrasound for Predicting Lymph Node Metastasis — Within 2 months after the completion of subject enrollment.
    This metric aims to evaluate the ability of the constructed multimodal deep learning model to correctly identify patients with papillary thyroid carcinoma who truly have cervical lymph node metastasis, under the optimal diagnostic threshold. Researchers need to collect the number of patients diagnosed with lymph node metastasis through postoperative pathology, as well as the number of patients predicted as "positive" (i.e., predicted to have metastasis) by the model, in order to calculate the sensitivity of the cervical ultrasound-based multimodal deep learning model in predicting lymph node metastasis. Calculation formula: Sensitivity = Number of true positive patients / Total number of positive patients confirmed by postoperative pathology.
  • Specificity of a Multimodal Deep Learning Model Based on Cervical Ultrasound for Predicting Lymph Node Metastasis — Within 2 months after the completion of subject enrollment.
    This metric aims to evaluate the ability of the constructed multimodal deep learning model to correctly rule out patients with papillary thyroid carcinoma who have not developed cervical lymph node metastasis, under the optimal diagnostic threshold. Researchers need to collect the number of patients diagnosed without lymph node metastasis via postoperative pathology, as well as the number of patients predicted by the model as "negative" (i.e., predicted to have no metastasis), in order to calculate the specificity of the cervical ultrasound-based multimodal deep learning model in predicting lymph node metastasis. Calculation formula: Specificity = Number of true negative patients / Total number of negative patients confirmed by postoperative pathology.

Trial sites (1)

FacilityCityRegionStatus
West China hospital of Sichuan University Chengdu Sichuan
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 NCT07299318 on ClinicalTrials.gov ↗ ← All trials in China