Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure

Study Overview
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Brief Summary
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This is a prospective, single-center, non-randomized, non-controlled observational study.

Detailed Description
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The negative predictive value of ultrasound for lymph node with neoadjuvant chemotherapy is low, magnetic resonance imaging (MRI) or PET/CT did not significantly improve specificity to axillary lymph node. The aim of this study is to determine performance of computed tomography (CT) reconstruction on evaluation of lymph node status after neoadjuvant chemotherapy in breast cancer patients.

Official Title
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Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure: a Prospective Observational Study Evaluating Response in Axillary Lymph Nodes of Breast Cancer After Neoadjuvant Chemotherapy

Conditions
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Invasive Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Invasive breast cancer with axillary lymph node metastasis by confirmed by fine needle aspiration (FNA) or core needle biopsy (CNB). Underwent computed tomography (CT) reconstruction for assessment of axillary lymph node status before and after neoadjuvant chemotherapy (NAC). Attend the study voluntarily, sign the informed consent. Exclusion Criteria: Contradiction for adjuvant chemotherapy. Contradiction for proceeding surgery.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| invasive breast cancer<br>Patients with invasive breast cancer who underwent computed tomography (CT) reconstruction of axillary lymph node for assessment of lymph node response after NAC are eligible for this study. Axillary lymph node metastasis is confirmed by fine needle aspiration (FNA) or core needle biopsy (CNB) at initial diagnosis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of Computed tomography (CT) reconstruction for axillary lymph node status after neoadjuvant chemotherapy. | Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of Computed tomography (CT) reconstruction for axillary lymph node status after neoadjuvant chemotherapy will be assessed. | within 6 weeks after obtaining the post-surgery pathological results | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rreceiver operating characteristic (ROC) curve analysis | The diagnostic performance of computed tomography (CT) reconstruction for the evaluation of ALN after NAC was evaluated with receiver operating characteristic (ROC) curve analysis. The diagnostic accuracy was estimated by calculating the area under the ROC curve. | within 6 weeks after obtaining the post-surgery pathological results | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Computed tomography (CT) reconstruction, axillary lymph node status