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

Breast Neoplasms Clinical Trial

Official title:
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

Clinical Trial Summary

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

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03791840
Study type Observational
Source Peking University People's Hospital
Contact
Status Completed
Phase
Start date December 1, 2017
Completion date July 1, 2022
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