Role of Ultrasound-Guided Lymph Node Biopsy in Axillary Staging of Breast Cancer.
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound-guided axillary lymph nodes FNAC and\or CNB.
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Axillary Lymph Node Biopsy in Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed patients with operable breast cancer regardless of whether lymph nodes are suspicious or not.
Exclusion Criteria:
- Patients who had previously undergone axillary surgery.
- Patients with metastatic disease and not planned for axillary surgery.
- Patients with a preoperative diagnosis of a benign lesion or ductal carcinoma in situ.
- Patients with severe uncorrectable bleeding diathesis.
- Patients refused to sign consent.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with operable breast cancer
Arm Description
Ultrasound-guided axillary lymph nodes FNAC and\or CNB.
Outcomes
Primary Outcome Measures
Diagnostic accuracy of preoperative ultrasound-guided axillary lymph node biopsy for staging in patients with newly diagnosed breast cancer.
Accuracy will be determined by comparing the results of ultrasound-guided axillary lymph node biopsy to the gold standard which is the final pathological results from sentinel lymphadenectomy or axillary lymph node dissection.
Secondary Outcome Measures
Accuracy of ultrasound-guided fine needle aspiration cytology and core needle biopsy in their ability to detect metastatic disease in the axillary lymph nodes of patients with a recent diagnosis of ipsilateral breast cancer.
Ultrasound-guided fine needle aspiration and\or core needle biopsy of axillary lymph node of the patient.
Full Information
NCT ID
NCT03681418
First Posted
September 20, 2018
Last Updated
September 21, 2018
Sponsor
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT03681418
Brief Title
Role of Ultrasound-Guided Lymph Node Biopsy in Axillary Staging of Breast Cancer.
Official Title
Role of Ultrasound-Guided Lymph Node Biopsy in Axillary Staging of Breast Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2018 (Anticipated)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of the study is to estimate the diagnostic accuracy of preoperative ultrasound-guided axillary lymph node biopsy for staging in patients with newly diagnosed breast cancer, and also to compare between ultrasound-guided fine needle aspiration cytology and core needle biopsy in their ability to detect metastatic disease in the axillary lymph nodes of patients with breast cancer.
Detailed Description
Axillary lymph node status is an extremely important prognostic factor in the assessment and treatment evaluation of patients with newly diagnosed breast cancer. Historically, axillary lymph node dissection (ALND) has been the reference standard for diagnosis and staging. However, this procedure can cause numerous postoperative problems, such as lymphedema , pain, impaired shoulder mobility and arm weakness. Furthermore, in this era of mammographic screening, axillary lymph node dissection yields negative results in 80%-85% of patients with T1 cancer.
Therefore, in recent years, sentinel lymph node biopsy (SNB) has replaced axillary dissection for lymph node staging at major medical centers. However, there are some practical issues to be resolved. For example, radiotracer distribution can be slow or faulty, valuable operating room time is expended, and pathologists must make quick decisions based on the analysis of frozen sections or there is the need to undergo two surgical interventions (i.e., removal of primary tumor and SNB, and in a next step completion ALND). If nodal positivity could be proven and documented preoperatively, sentinel lymph node biopsy could be bypassed and a decision will be made to perform axillary dissection, which is the standard of care in most node-positive patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Axillary Lymph Node Biopsy in Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with operable breast cancer
Arm Type
Other
Arm Description
Ultrasound-guided axillary lymph nodes FNAC and\or CNB.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided axillary lymph nodes FNAC and\or CNB.
Intervention Description
Ultrasound-guided axillary lymph node fine needle aspiration and\or core needle biopsy of the most suspicious lymph node. If all the lymph nodes appeared similar or normal, the lymph node that is lowest in the axilla will be selected because it is considered to most likely be the sentinel node.
Primary Outcome Measure Information:
Title
Diagnostic accuracy of preoperative ultrasound-guided axillary lymph node biopsy for staging in patients with newly diagnosed breast cancer.
Description
Accuracy will be determined by comparing the results of ultrasound-guided axillary lymph node biopsy to the gold standard which is the final pathological results from sentinel lymphadenectomy or axillary lymph node dissection.
Time Frame
Baseline.
Secondary Outcome Measure Information:
Title
Accuracy of ultrasound-guided fine needle aspiration cytology and core needle biopsy in their ability to detect metastatic disease in the axillary lymph nodes of patients with a recent diagnosis of ipsilateral breast cancer.
Description
Ultrasound-guided fine needle aspiration and\or core needle biopsy of axillary lymph node of the patient.
Time Frame
Baseline.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed patients with operable breast cancer regardless of whether lymph nodes are suspicious or not.
Exclusion Criteria:
Patients who had previously undergone axillary surgery.
Patients with metastatic disease and not planned for axillary surgery.
Patients with a preoperative diagnosis of a benign lesion or ductal carcinoma in situ.
Patients with severe uncorrectable bleeding diathesis.
Patients refused to sign consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mai M. Khedrawy, M.B.B.CH
Phone
00201028655822
Email
mai.4cj@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai M. Khedrawy, M.B.B.CH
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hassan I. Metgally, professor
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Momtaz T. Allam, Lecturer
Organizational Affiliation
Assiut University
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
12374657
Citation
Swenson KK, Nissen MJ, Ceronsky C, Swenson L, Lee MW, Tuttle TM. Comparison of side effects between sentinel lymph node and axillary lymph node dissection for breast cancer. Ann Surg Oncol. 2002 Oct;9(8):745-53. doi: 10.1007/BF02574496.
Results Reference
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PubMed Identifier
12515869
Citation
Kumar R, Jana S, Heiba SI, Dakhel M, Axelrod D, Siegel B, Bernik S, Mills C, Wallack M, Abdel-Dayem HM. Retrospective analysis of sentinel node localization in multifocal, multicentric, palpable, or nonpalpable breast cancer. J Nucl Med. 2003 Jan;44(1):7-10.
Results Reference
background
PubMed Identifier
20966338
Citation
Mainiero MB, Cinelli CM, Koelliker SL, Graves TA, Chung MA. Axillary ultrasound and fine-needle aspiration in the preoperative evaluation of the breast cancer patient: an algorithm based on tumor size and lymph node appearance. AJR Am J Roentgenol. 2010 Nov;195(5):1261-7. doi: 10.2214/AJR.10.4414.
Results Reference
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Role of Ultrasound-Guided Lymph Node Biopsy in Axillary Staging of Breast Cancer.
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