The Accuracy of Sentinel Node Biopsy of Breast Cancer With Sonographic Abnormal Axillary Lymph Nodes
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|ClinicalTrials.gov Identifier: NCT02005926|
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : June 18, 2014
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Wire-localized abnormal node||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trail of Removing Sonographic Abnormal Lymph Node in Sentinel Lymph Node Biopsy of Breast Cancer Patient|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||June 2014|
Experimental: negative FNA result of abnormal node
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
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.
- False negative rate of sentinel node biopsy if sonographic abnormal node not be removed [ Time Frame: one week after sentinel node biopsy ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005926
|Breast cancer, Peking University Cancer Hospital & Institute|
|Beijing, China, 100142|
|Principal Investigator:||Zhaoqing Fan, M.D.||Peking University Cancer Hospital & Institute|