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

NCT02005926 | Completed Phase 2

• 1 other identifier: BCP07
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Breast Cancer

Keywords

Breast cancer; Sentinel lymph node biopsy; Ultrasonography; Fine needle aspiration

Outcome Measures

Primary Outcomes (1)

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

  one week after sentinel node biopsy

Study Arms (1)

negative FNA result of abnormal node

EXPERIMENTAL

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

Interventions

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.

negative FNA result of abnormal node

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tao OUYANG: lead

Study Sites (1)

Breast cancer, Peking University Cancer Hospital & Institute

Beijing, 100142, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhaoqing Fan, M.D.

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman of Breast Center

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 9, 2013
• Study Start: May 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 18, 2014

Record last verified: 2014-06

Locations

CN (1)