Ultrasound Monitoring of Clipped Lymph Nodes to Predict Axillary Response After Chemotherapy in Breast Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 1 trial group
Group A: Breast cancer patients with clipped axillary lymph nodes receiving NAC and ultrasound follow-up.

Trial outcomes

Primary outcomes

1

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.

Time frame
At the time of postoperative pathological assessment (usually within 1 week after surgery)
2

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.

Time frame
At the time of postoperative pathological assessment (usually within 1 week after surgery).

Secondary outcomes

Other outcomes

Sponsors and contacts

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