About this trial
This study aims to evaluate whether longitudinal multimodal ultrasound can accurately predict axillary pathological response in breast cancer patients who receive neoadjuvant chemotherapy. In this study, patients with biopsy-proven metastatic axillary lymph nodes will have a metallic clip placed in the positive node before chemotherapy. During and after treatment, the clipped lymph node will be monitored by ultrasound, including gray-scale imaging, shear wave elastography, and contrast-enhanced ultrasound. The changes in the morphological and functional features of the clipped node will be analyzed to establish a predictive model for axillary pathological complete response. The results are expected to help identify patients who may safely avoid unnecessary axillary lymph node dissection and improve individualized surgical decision-making.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged 18 years or older.
Disqualifiers
Bilateral breast cancer.
Trial population
Patients with histologically confirmed invasive breast cancer and biopsy-proven metastatic axillary lymph nodes who will receive standard neoadjuvant chemotherapy. All enrolled patients will have a metallic clip placed in the biopsied positive lymph node before treatment, undergo longitudinal multimodal ultrasound examinations during and after NAC, and finally receive surgery with postoperative pathological evaluation of axillary lymph nodes.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Diagnostic performance of predictive model for axillary pathological complete response (ax-pCR)
Area under the ROC curve (AUC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the multimodal ultrasound-based predictive model for ax-pCR.
Diagnostic performance of predictive model for axillary pathological complete response (ax-pCR)
Area under the ROC curve (AUC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the multimodal ultrasound-based predictive model for ax-pCR.
Sponsors and contacts
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