Ultrasound Monitoring of Clipped Lymph Nodes to Predict Axillary Response After Chemotherapy in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Axillary Lymph Node Metastasis, Neoadjuvant Chemotherapy, Pathological Complete Response. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Primary outcome measures
- Diagnostic performance of predictive model for axillary pathological complete response (ax-pCR) [Time frame: At the time of postoperative pathological assessment (usually within 1 week after surgery)]
- Diagnostic performance of predictive model for axillary pathological complete response (ax-pCR) [Time frame: At the time of postoperative pathological assessment (usually within 1 week after surgery).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT07596472 · SYSKY-2025-752-01