Clinical trial NCT03681418: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Axillary Lymph Node Biopsy in Breast Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Diagnostic accuracy of preoperative ultrasound-guided axillary lymph node biopsy for staging in patients with newly diagnosed breast cancer.
timeFrame: Baseline.
Secondary outcomes:
measure: 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.
timeFrame: Baseline.
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mai M. Khedrawy, M.B.B.CH
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Hassan I. Metgally, professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Momtaz T. Allam, Lecturer
role: STUDY_DIRECTOR
References:
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.
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.
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.