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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tao OUYANG, Peking University
ClinicalTrials.gov Identifier:
NCT02005926
First received: December 4, 2013
Last updated: June 16, 2014
Last verified: June 2014

December 4, 2013
June 16, 2014
May 2010
May 2014   (final data collection date for primary outcome measure)
False negative rate of sentinel node biopsy if sonographic abnormal node not be removed [ Time Frame: one week after sentinel node biopsy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02005926 on ClinicalTrials.gov Archive Site
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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
  • 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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
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.
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.
Intervention: Procedure: Wire-localized abnormal node
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
June 2014
May 2014   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT02005926
BCP07
No
Tao OUYANG, Peking University
Tao OUYANG
Not Provided
Principal Investigator: Zhaoqing Fan, M.D. Peking University Cancer Hospital & Institute
Peking University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP