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

Sponsor

Tao OUYANG (Other)

Overall Status

Completed

CT.gov ID

NCT02005926

Collaborator

(none)

200

Enrollment

Location

Arm

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Procedure: Wire-localized abnormal node	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

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

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

False negative rate of sentinel node biopsy if sonographic abnormal node not be removed [one week after sentinel node biopsy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tao OUYANG, Chairman of Breast Center, Peking University

ClinicalTrials.gov Identifier:

NCT02005926

Other Study ID Numbers:

BCP07

First Posted:

Dec 9, 2013

Last Update Posted:

Jun 18, 2014

Last Verified:

Jun 1, 2014

Keywords provided by Tao OUYANG, Chairman of Breast Center, Peking University

Breast cancer

Sentinel lymph node biopsy

Ultrasonography

Fine needle aspiration

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Jun 18, 2014