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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02005926
First Posted: December 9, 2013
Last Update Posted: June 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tao OUYANG, Peking University
  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: Intervention Model: Single Group Assignment
Masking: None (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 Tao OUYANG, 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 ]

Estimated Enrollment: 200
Study Start Date: May 2010
Study Completion Date: June 2014
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005926


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

Responsible Party: Tao OUYANG, Chairman of Breast Center, Peking University
ClinicalTrials.gov Identifier: NCT02005926     History of Changes
Other Study ID Numbers: BCP07
First Submitted: December 4, 2013
First Posted: December 9, 2013
Last Update Posted: June 18, 2014
Last Verified: June 2014

Keywords provided by Tao OUYANG, 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