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

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ClinicalTrials.gov Identifier: NCT01920139
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : August 9, 2013
Sponsor:
Collaborator:
Suros Surgical (now Hologic )
Information provided by (Responsible Party):
Marie Ganott, 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.

Condition or disease Intervention/treatment Phase
Focus: Breast Cancer With Axillary Node Metastasis Procedure: Fine needle aspiration and core biopsy of lymph node Procedure: Axillary surgery Other: Titanium marker Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ultrasound Guided Core Biopsy vs Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy in Patients Suspected of Having Breast Cancer.
Study Start Date : December 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Breast cancer and Axillary Adenopathy
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
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.

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

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




Primary Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920139


Locations
United States, Pennsylvania
Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Suros Surgical (now Hologic )

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marie Ganott, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01920139     History of Changes
Other Study ID Numbers: PRO07100450
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Breast Neoplasms
Lymphadenopathy
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases