The Value of High-resolution Ultrasound in the Detection of Lymph Node Metastasis: a Proposal of NI-RADS

Study Overview
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Brief Summary
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The status of axillary lymph node (ALN) is an important reference indicator for breast cancer surgery and systemic treatment, which is also an important prognostic indicator for breast cancer. Therefore, it is extremely important for surgeons to accurately determine whether axillary lymph nodes have metastasis and the number of metastatic lymph nodes. The value of ultrasound diagnosing the status of axillary lymph nodes was controversial in recent publications. Therefore, there is a high need to prove the accuracy and precision of ultrasound for axillary lymph node metastasis in breast cancer patients. The aim of this study is to assess the usefulness of ultrasound in the diagnosis of axillary lymph node status in breast cancer patients by gathering in vivo and vitro ultrasonographic parameters to build a clinical useful categorization system

Detailed Description
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To facilitate the non-invasive assessment of lymph node status preoperatively, we use ultrasound to detect lymph node metastasis. We designed this study to obtain in vivo and vitro ultrasound features and parameters. Before surgery, the detailed ultrasound features are collected during routine ultrasound examination. After the completion of the axillary surgery, fresh lymph node specimens are collected for in vitro ultrasound evaluation one by one in a specially-designed detection system. Statistical models are built to categorize the probability of metastasis of lymph node according to a proposed categorization system similar as BI-RADS(Breast Imaging Reporting and Data System), which is named NI-RADS (Node Imaging Reporting and Data System).

Official Title
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The Accuracy of High-resolution Ultrasound in the Detection of Lymph Node Metastasis From Breast Cancer and the Proposal of Node Imaging Reporting and Data System

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Diagnostic Test: Ultrasound evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed invasive breast cancer. Pathological axillary lymph node staging planned. Axillary lymph node not removed prior to the study. Exclusion Criteria: Refusal participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ultrasound evaluation<br>Eligible patients undergo lymph node biopsy or lymph node dissection. Before surgery, the status of axillary lymph node status was evaluated using ultrasound. After surgery, all lymph node specimens would be collected and be assessed using ultrasound in a special evaluation system in vitro. | Diagnostic Test: Ultrasound evaluation<br>* High-frequency ultrasound is used to detected the lymph node metastasis in vivo and vitro. The lymph node number, morphology and elastographic parameters are collected in the patients and in fresh lymph node specimens.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of ultrasound | True positive rate measures the proportion of positives that are correctly identified by ultrasound | Through study completion, an average of 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of ultrasound | The true negative rate measures the proportion of negatives that are correctly identified. | Through study completion, an average of 1 year. | 
| Diagnostic model of lymph node ultrasound | A diagnostic model or nomogram would be developed to facilitate the diagnosis of the lymph node ultrasound. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast neoplasms, Ultrasonography, Interventional, Biopsy, Large-Core Needle, Biopsy, Fine-Needle