Clinical trial · Observational
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
- 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)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Axillary Lymph Node Metastasis | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Neoadjuvant Chemotherapy | — | UNRESOLVED | — |
| Pathological Complete Response | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Breast cancer patients with clipped axillary lymph nodes receiving NAC and ultrasound follow-up.
Primary outcomes (2)
- measure
- Diagnostic performance of predictive model for axillary pathological complete response (ax-pCR)
- timeFrame
- At the time of postoperative pathological assessment (usually within 1 week after surgery)
- description
- 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.
- measure
- Diagnostic performance of predictive model for axillary pathological complete response (ax-pCR)
- timeFrame
- At the time of postoperative pathological assessment (usually within 1 week after surgery).
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available