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

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT01920139

Collaborator

Suros Surgical (now Hologic ) (Other)

105

Enrollment

Location

Arm

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

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.

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	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

N/A

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 :

Dec 1, 2008

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

Fraction of metastatic nodes found at axillary surgery that were identified pre-surgically by FNA vs. core biopsy [1 week to 10 months]
Results of FNA cytology and core biopsy histology are compared to axillary surgery results.

Other Outcome Measures

Pain associated with each type of percutaneous biopsy procedure [immediate at time of biopsy]
Patients were asked to report pain level during the 2 types of percutaneous biopsy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Magee Womens Hospital	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

University of Pittsburgh
Suros Surgical (now Hologic )

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marie Ganott, MD, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT01920139

Other Study ID Numbers:

PRO07100450

First Posted:

Aug 9, 2013

Last Update Posted:

Aug 9, 2013

Last Verified:

Aug 1, 2013

Additional relevant MeSH terms:

Breast Neoplasms

Lymphadenopathy

Study Results

No Results Posted as of Aug 9, 2013