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

Focus: Breast Cancer With Axillary Node Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920139
• Other study ID #: PRO07100450
• Status: Completed
• Phase: N/A
• First received: August 1, 2013
• Last updated: August 6, 2013
• Start date: December 2008
• Est. completion date: June 2011

Study information

• Verified date: August 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: University of Pittsburgh Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Focus: Breast Cancer With Axillary Node Metastasis
• Lymphatic Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Magee Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Magee Womens Hospital foundation, Suros Surgical (now Hologic )

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain associated with each type of percutaneous biopsy procedure	Patients were asked to report pain level during the 2 types of percutaneous biopsy.	immediate at time of biopsy	No
Primary	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	No