Clinical trial · Observational
The Value of High-resolution Ultrasound in the Detection of Lymph Node Metastasis: a Proposal of NI-RADS
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound evaluation | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ultrasound evaluation
- description
- 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.
- interventionNames
- Diagnostic Test: Ultrasound evaluation
Primary outcomes (1)
- measure
- Sensitivity of ultrasound
- timeFrame
- Through study completion, an average of 1 year.
- description
- True positive rate measures the proportion of positives that are correctly identified by ultrasound
Secondary outcomes (2)
- measure
- Specificity of ultrasound
- timeFrame
- Through study completion, an average of 1 year.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTHan 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. PMID 32146007