Back to resultsThe Accuracy of Sentinel Node Biopsy of Breast Cancer With Sonographic Abnormal Axillary Lymph Nodes
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Wire-localized abnormal node
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast cancer, Sentinel lymph node biopsy, Ultrasonography, Fine needle aspiration
Eligibility 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
Sites / Locations
- Breast cancer, Peking University Cancer Hospital & Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
negative FNA result of abnormal node
Arm Description
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.
Outcomes
Primary Outcome Measures
False negative rate of sentinel node biopsy if sonographic abnormal node not be removed
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02005926
Brief Title
The Accuracy of Sentinel Node Biopsy of Breast Cancer With Sonographic Abnormal Axillary Lymph Nodes
Official Title
Phase II Trail of Removing Sonographic Abnormal Lymph Node in Sentinel Lymph Node Biopsy of Breast Cancer Patient
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tao OUYANG
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Sentinel lymph node biopsy, Ultrasonography, Fine needle aspiration
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
negative FNA result of abnormal node
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Wire-localized abnormal node
Intervention Description
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.
Primary Outcome Measure Information:
Title
False negative rate of sentinel node biopsy if sonographic abnormal node not be removed
Time Frame
one week after sentinel node biopsy
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoqing Fan, M.D.
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Breast cancer, Peking University Cancer Hospital & Institute
City
Beijing
ZIP/Postal Code
100142
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Accuracy of Sentinel Node Biopsy of Breast Cancer With Sonographic Abnormal Axillary Lymph Nodes
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