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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02005926

Enrollment

200

Registered

2013-12-09

Start date

2010-05-31

Completion date

2014-06-30

Last updated

2014-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, Sentinel lymph node biopsy, Ultrasonography, Fine needle aspiration

Brief summary

* 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.

Interventions

PROCEDUREWire-localized abnormal node

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
False negative rate of sentinel node biopsy if sonographic abnormal node not be removed	one week after sentinel node biopsy

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026