Role of Ultrasound-Guided Lymph Node Biopsy in Axillary Staging of Breast Cancer.

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Ultrasound-guided axillary lymph nodes FNAC and\or CNB.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mai M. Khedrawy, M.B.B.CH; Phone Number: 00201028655822; Email: mai.4cj@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with operable breast cancer; Ultrasound-guided axillary lymph nodes FNAC and\or CNB.	Procedure: Ultrasound-guided axillary lymph nodes FNAC and\or CNB.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline.

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Mai M. Khedrawy, M.B.B.CH, Assiut University; Study Director: Hassan I. Metgally, professor, Assiut University; Study Director: Momtaz T. Allam, Lecturer, Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 24, 2018
• Last Update Submitted That Met QC Criteria: September 21, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Axillary Lymph Node Biopsy in Breast Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: LNs Staging of Breast cancer

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No