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

This study is currently recruiting participants.
Verified March 2010 by Peking University
Sponsor:
Information provided by (Responsible Party):
Tao OUYANG, Peking University
ClinicalTrials.gov Identifier:
NCT02005926
First received: December 4, 2013
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose
  • 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 Intervention Phase
Breast Cancer
Procedure: Wire-localized abnormal node
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase II Trail of Removing Sonographic Abnormal Lymph Node in Sentinel Lymph Node Biopsy of Breast Cancer Patient

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: May 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02005926

Contacts
Contact: Tao Ouyang, M.D. 861088196695 ouyanghongtao@263.net
Contact: Zhaoqing Fan, M.D. 861088196012 zhqfan@yahoo.com

Locations
China
Breast cancer, Peking University Cancer Hospital & Institute Recruiting
Beijing, China, 100142
Principal Investigator: Zhaoqing Fan, M.D.         
Sponsors and Collaborators
Tao OUYANG
Investigators
Principal Investigator: Zhaoqing Fan, M.D. Peking University Cancer Hospital & Institute
  More Information

No publications provided

Responsible Party: Tao OUYANG, Chairman of Breast Center, Peking University
ClinicalTrials.gov Identifier: NCT02005926     History of Changes
Other Study ID Numbers: BCP07
Study First Received: December 4, 2013
Last Updated: December 4, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University:
Breast cancer
Sentinel lymph node biopsy
Ultrasonography
Fine needle aspiration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 15, 2014