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OpenTrials
Completed

NCT Number: NCT01920139

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

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.

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Key information

Conditions

Focus: Breast Cancer With Axillary Node Metastasis

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fine needle aspiration and core biopsy of lymph node

Procedure

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.

Axillary Surgery

Procedure

Patients underwent axillary node dissection or excision of setinel axillary nodes at the time of surgical treatment of their breast cancer.

Titanium marker

Other

A titanium marker was deposited into the lymph node that was percutaneously biopsied , immediately after the last tissue sample obtained.

Primary outcomes

  1. Fraction of metastatic nodes found at axillary surgery that were identified pre-surgically by FNA vs. core biopsy

    Time frame: 1 week to 10 months

    Results of FNA cytology and core biopsy histology are compared to axillary surgery results.

Other outcomes

  1. Pain associated with each type of percutaneous biopsy procedure

    Time frame: immediate at time of biopsy

    Patients were asked to report pain level during the 2 types of percutaneous biopsy.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Suros Surgical (now Hologic )

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 9, 2013
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.