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

Phase 2CompletedNCT02005926

Tao OUYANG200 enrolled

Overview

* 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

200

Conditions

Breast Cancer

Interventions

Wire-localized abnormal nodePROCEDURE

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.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (1)

Breast cancer, Peking University Cancer Hospital & Institute

Beijing, China

Outcomes

Primary Outcomes

False negative rate of sentinel node biopsy if sonographic abnormal node not be removed

Time frame: one week after sentinel node biopsy

Data from ClinicalTrials.gov

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