Ultrasound Guided Core Biopsy vs Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy

Study Overview
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Brief Summary
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The study was performed to determine if either ultrasound guided core biopsy or fine needle aspiration of an axillary lymph node has superior sensitivity in detecting metastatic carcinoma from the ipsilateral breast.

Detailed Description
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Women with suspected or recently diagnosed breast cancer and ipsilateral abnormal appearing axillary lymph nodes underwent fine needle aspiration immediately followed by core biopsy of the same lymph node.Cytology results from the fine needle aspiration (FNA)and histology from the core biopsy were compared to surgical pathology from axillary node excision to determine if either method of percutaneous node sampling was more sensitive in detecting metastasis. Pain during each procedure was also compared.

Official Title
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Ultrasound Guided Core Biopsy vs Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy in Patients Suspected of Having Breast Cancer.

Conditions
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Focus: Breast Cancer With Axillary Node Metastasis

Intervention / Treatment
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* Procedure: Fine needle aspiration and core biopsy of lymph node
* Procedure: Axillary surgery
* Other: Titanium marker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with breast cancer and abnormal ipsilateral axillary nodes visible on sonography. Exclusion Criteria: Inability to understand consent form. Emotionally unprepared to discuss possibility of axillary metastasis Node not amenable to core biopsy
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Breast cancer and Axillary Adenopathy<br>Women with breast cancer with abnormal appearing ipsilateral axillary nodes undergoing fine needle aspiration and core biopsy of a lymph node. | Procedure: Fine needle aspiration and core biopsy of lymph node<br>* Ultrasound guided fine needle aspiration of an abnormal lymph node followed by ultrasound guided core biopsy of the same node followed by clip placement into the node.<br>Procedure: Axillary surgery<br>* Patients underwent axillary node dissection or excision of setinel axillary nodes at the time of surgical treatment of their breast cancer.<br>Other: Titanium marker<br>* A titanium marker was deposited into the lymph node that was percutaneously biopsied , immediately after the last tissue sample obtained.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fraction of metastatic nodes found at axillary surgery that were identified pre-surgically by FNA vs. core biopsy | Results of FNA cytology and core biopsy histology are compared to axillary surgery results. | 1 week to 10 months |