The Accuracy of Sentinel Node Biopsy of Breast Cancer With Sonographic Abnormal Axillary Lymph Nodes

Study Overview
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Brief Summary
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This is a phase II, prospective, single-center, non-randomized, non-controlled study. Sentinel lymph node biopsy (SNB) is a standard staging procedure in early breast cancer. The potentially increasing false negative rate of SNB was concerned if the sonographic abnormal node was not excised. The aim of this study was to evaluate the accuracy of SNB in breast cancer with sonographic abnormal axillary lymph nodes.

Official Title
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Phase II Trail of Removing Sonographic Abnormal Lymph Node in Sentinel Lymph Node Biopsy of Breast Cancer Patient

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Wire-localized abnormal node


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmsed primary breast cancer by core neelde biopsy or excisional biospy abnormal axillary lymph node was found by ultrasound examination before SLNB (abnormal nodes were defined as completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation and cortical thickness >3mm) ultrasound-guided FNA cytology of these nodes were performed the result of FNA cytology was negative (no tumour cell was found) patient planed to perform SLNB Exclusion Criteria: pathological diagnosed ductal carcinoma in situ by excisional biospy abnormal axillary lymph node was found by ultrasound examination but FNA cytology of these nodes were not performed the result of FNA cytology was positive (tumour cell was found) T4d tumour patient has recieved neo-adjuvant system therapy
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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: negative FNA result of abnormal node<br>Axillary ultrasound examination was undergone for all breast cancer patients before sentinel lymph node biopsy (SLNB). If abnormal axillary lymph node was found, ultrasound-guided FNA cytology of these nodes were performed. The abnormal nodes were defined as completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation and cortical thickness >3mm. Patients with negative results of FNA would undergo SLNB. Technetium-99m-labeled Rituximab was used for lymphatic mapping. Before the SLNB operation, a hookwire was placed at the suspicious axillary lymph node by ultrasound guidance. In the SLNB operation, radioactive nodes and wire-localized nodes were removed and labeled separately for pathological examination. | Procedure: Wire-localized abnormal node<br>* Before the sentinel lymph node biopsy (SLNB) operation, a hookwire was placed at the suspicious axillary lymph node by ultrasound guidance to localize the abnormal node. In the SLNB operation, radioactive nodes and wire-localized nodes were removed and labeled separately for pathological examination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| False negative rate of sentinel node biopsy if sonographic abnormal node not be removed |  | one week after sentinel node biopsy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Sentinel lymph node biopsy, Ultrasonography, Fine needle aspiration