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

A Prospective Diagnostic Clinical Study Based on Longitudinal Multimodal Ultrasound Evaluation of Clipped Lymph Nodes to Assess Axillary Pathological Response After Neoadjuvant Chemotherapy in Breast Cancer

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07596472

Enrollment

150

Registered

2026-05-19

Start date

2026-05-20

Completion date

2027-05-20

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axillary Lymph Node Metastasis, Breast Cancer, Neoadjuvant Chemotherapy, Pathological Complete Response

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Female patients aged 18 years or older. Clinical stage of breast cancer: T1-T4, N1-N3, M0. Axillary lymph node metastasis confirmed by fine-needle aspiration (FNA) or core-needle biopsy. Indicated for and planned to receive standard neoadjuvant chemotherapy (NAC) regimen. The biopsy-proven metastatic lymph node is clearly visible on ultrasound and suitable for clip placement. Completion of NAC followed by breast surgery and axillary lymph node dissection, with complete pathological results available. Underwent multimodal ultrasound monitoring during NAC, including conventional ultrasound, elastography, and contrast-enhanced ultrasound. Signed informed consent and willingness to complete all scheduled follow-ups.

Exclusion criteria

* Bilateral breast cancer. Patients who are not suitable for neoadjuvant chemotherapy or plan to receive endocrine or targeted therapy only. Prior breast or axillary surgery, chemotherapy, or other treatments that may affect the current therapeutic assessment. Presence of distant metastasis or extensive axillary invasion making clip placement or evaluation difficult. Pregnant or lactating women. Poor image quality on ultrasound or other imaging modalities. Inability to provide informed consent due to psychological, family, or social factors

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic performance of predictive model for axillary pathological complete response (ax-pCR)	At the time of postoperative pathological assessment (usually within 1 week after surgery)	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.

Countries

China

Contacts

CONTACTJingsi Mei

meijs@mail.sysu.edu.cn+8618825050526

Outcome results