Back to resultsUltrasound Guided Core Biopsy vs Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy
Primary Purpose
Focus: Breast Cancer With Axillary Node Metastasis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fine needle aspiration and core biopsy of lymph node
Axillary surgery
Titanium marker
Sponsored by
About this trial
This is an interventional diagnostic trial for Focus: Breast Cancer With Axillary Node Metastasis
Eligibility 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
Sites / Locations
- Magee Womens Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Breast cancer and Axillary Adenopathy
Arm Description
Women with breast cancer with abnormal appearing ipsilateral axillary nodes undergoing fine needle aspiration and core biopsy of a lymph node.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01920139
First Posted
August 1, 2013
Last Updated
August 6, 2013
Sponsor
University of Pittsburgh
Collaborators
Suros Surgical (now Hologic )
1. Study Identification
Unique Protocol Identification Number
NCT01920139
Brief Title
Ultrasound Guided Core Biopsy vs Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy
Official Title
Ultrasound Guided Core Biopsy vs Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy in Patients Suspected of Having Breast Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Suros Surgical (now Hologic )
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focus: Breast Cancer With Axillary Node Metastasis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breast cancer and Axillary Adenopathy
Arm Type
Other
Arm Description
Women with breast cancer with abnormal appearing ipsilateral axillary nodes undergoing fine needle aspiration and core biopsy of a lymph node.
Intervention Type
Procedure
Intervention Name(s)
Fine needle aspiration and core biopsy of lymph node
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Axillary surgery
Intervention Description
Patients underwent axillary node dissection or excision of setinel axillary nodes at the time of surgical treatment of their breast cancer.
Intervention Type
Other
Intervention Name(s)
Titanium marker
Intervention Description
A titanium marker was deposited into the lymph node that was percutaneously biopsied , immediately after the last tissue sample obtained.
Primary Outcome Measure Information:
Title
Fraction of metastatic nodes found at axillary surgery that were identified pre-surgically by FNA vs. core biopsy
Description
Results of FNA cytology and core biopsy histology are compared to axillary surgery results.
Time Frame
1 week to 10 months
Other Pre-specified Outcome Measures:
Title
Pain associated with each type of percutaneous biopsy procedure
Description
Patients were asked to report pain level during the 2 types of percutaneous biopsy.
Time Frame
immediate at time of biopsy
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Magee Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24649373
Citation
Ganott MA, Zuley ML, Abrams GS, Lu AH, Kelly AE, Sumkin JH, Chivukula M, Carter G, Austin RM, Bandos AI. Ultrasound Guided Core Biopsy versus Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy in Patients with Breast Cancer. ISRN Oncol. 2014 Feb 4;2014:703160. doi: 10.1155/2014/703160. eCollection 2014.
Results Reference
derived
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Ultrasound Guided Core Biopsy vs Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy
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