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

Not Applicable

Completed

• Conditions: Focus: Breast Cancer With Axillary Node Metastasis
• Interventions: Procedure: Fine needle aspiration and core biopsy of lymph node; Procedure: Axillary surgery; Other: Titanium marker

• Registration Number: NCT01920139
• Lead Sponsor: University of Pittsburgh

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-08
• Study First Submitted: 2013-08-01
• Study First Submitted QC: 2013-08-06
• Last Update Submitted: 2013-08-06
• Study First Posted: 2013-08-09
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

• Women with breast cancer and abnormal ipsilateral axillary nodes visible on sonography.

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Exclusion Criteria

• Inability to understand consent form.
• Emotionally unprepared to discuss possibility of axillary metastasis
• Node not amenable to core biopsy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breast cancer and Axillary Adenopathy	Fine needle aspiration and core biopsy of lymph node	Women with breast cancer with abnormal appearing ipsilateral axillary nodes undergoing fine needle aspiration and core biopsy of a lymph node.
Breast cancer and Axillary Adenopathy	Axillary surgery	Women with breast cancer with abnormal appearing ipsilateral axillary nodes undergoing fine needle aspiration and core biopsy of a lymph node.
Breast cancer and Axillary Adenopathy	Titanium marker	Women with breast cancer with abnormal appearing ipsilateral axillary nodes undergoing fine needle aspiration and core biopsy of a lymph node.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Magee Womens Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States