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

Completed

• Conditions: Breast Neoplasms
• Interventions: Diagnostic Test: Ultrasound evaluation

• Registration Number: NCT03791840
• Lead Sponsor: Peking University People's Hospital

Brief 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

Detailed 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 Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-12-31
• Study First Submitted QC: 2018-12-31
• Primary Completion: 2019-01-01
• Study First Posted: 2019-01-03
• Study Completion: 2022-07-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 135

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ultrasound evaluation	Ultrasound evaluation	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity of ultrasound	Through study completion, an average of 1 year.	True positive rate measures the proportion of positives that are correctly identified by ultrasound

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China