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

Breast Neoplasms Clinical Trial

— NI-RADS  

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 Details — Status: Completed

Administrative data

• NCT number: NCT03791840
• Other study ID #: PKUPHUS002
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: July 1, 2022

Study information

• Verified date: October 2022
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: July 1, 2022
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Lymphatic Metastasis

Intervention

Diagnostic Test:
• Ultrasound evaluation
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.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Han P, Yang H, Liu M, Cheng L, Wang S, Tong F, Liu P, Zhou B, Cao Y, Liu H, Wang C, Peng Y, Shen D, Wang S. Lymph Node Predictive Model with in Vitro Ultrasound Features for Breast Cancer Lymph Node Metastasis. Ultrasound Med Biol. 2020 Jun;46(6):1395-140 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Specificity of ultrasound	The true negative rate measures the proportion of negatives that are correctly identified.	Through study completion, an average of 1 year.
Secondary	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