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

* 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Breast cancer, Peking University Cancer Hospital & Institute

Beijing, 100142, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wire-localized abnormal node

Procedure

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.

Primary outcomes

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

Time frame: one week after sentinel node biopsy

Sponsors and collaborators

Lead sponsor

Tao OUYANG

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Dec 9, 2013
Registry last updated: Jun 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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