Breast Neoplasms
Conditions
Keywords
breast neoplasms, Ultrasonography, Interventional, Biopsy, Large-Core Needle, Biopsy, Fine-Needle
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).
Interventions
DIAGNOSTIC_TESTUltrasound 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.
Sponsors
Peking University People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Specificity of ultrasound | Through study completion, an average of 1 year. | The true negative rate measures the proportion of negatives that are correctly identified. |
| 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. |
Countries
China
Outcome results
None listed