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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01920139
Enrollment
105
Registered
2013-08-09
Start date
2008-12-31
Completion date
2011-06-30
Last updated
2013-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focus: Breast Cancer With Axillary Node Metastasis

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.

Interventions

PROCEDUREFine 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.

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

OTHERTitanium marker

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

Sponsors

Suros Surgical (now Hologic )
CollaboratorUNKNOWN
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fraction of metastatic nodes found at axillary surgery that were identified pre-surgically by FNA vs. core biopsy1 week to 10 monthsResults of FNA cytology and core biopsy histology are compared to axillary surgery results.

Other

MeasureTime frameDescription
Pain associated with each type of percutaneous biopsy procedureimmediate at time of biopsyPatients were asked to report pain level during the 2 types of percutaneous biopsy.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026