Ultrasound Guided Core Biopsy vs Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy
1 other identifier
interventional
105
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 1, 2013
CompletedFirst Posted
Study publicly available on registry
August 9, 2013
CompletedAugust 9, 2013
August 1, 2013
2.5 years
August 1, 2013
August 6, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Other Outcomes (1)
Pain associated with each type of percutaneous biopsy procedure
immediate at time of biopsy
Study Arms (1)
Breast cancer and Axillary Adenopathy
OTHERWomen with breast cancer with abnormal appearing ipsilateral axillary nodes undergoing fine needle aspiration and core biopsy of a lymph node.
Interventions
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.
Patients underwent axillary node dissection or excision of setinel axillary nodes at the time of surgical treatment of their breast cancer.
A titanium marker was deposited into the lymph node that was percutaneously biopsied , immediately after the last tissue sample obtained.
Eligibility Criteria
You may qualify if:
- Women with breast cancer and abnormal ipsilateral axillary nodes visible on sonography.
You may not qualify if:
- Inability to understand consent form.
- Emotionally unprepared to discuss possibility of axillary metastasis
- Node not amenable to core biopsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- Suros Surgical (now Hologic )collaborator
Study Sites (1)
Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
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.
PMID: 24649373DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 1, 2013
First Posted
August 9, 2013
Study Start
December 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
August 9, 2013
Record last verified: 2013-08