Clinical trial NCT03791840: The Value of High-resolution Ultrasound in the Detection of Lymph Node Metastasis: a Proposal of 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Keywords: breast neoplasms
Ultrasonography, Interventional
Biopsy, Large-Core Needle
Biopsy, Fine-Needle
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with invasive breast cancer planned to receive surgical axillary lymph node staging are eligible.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity of ultrasound
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Specificity of ultrasound
timeFrame: Through study completion, an average of 1 year.
measure: Diagnostic model of lymph node ultrasound
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Shu Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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):1395-1402. doi: 10.1016/j.ultrasmedbio.2020.01.030. Epub 2020 Mar 5.