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

NCT ID: NCT01920139

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Focus: Breast Cancer With Axillary Node Metastasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Fine needle aspiration and core biopsy of lymph node

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Titanium marker

Intervention Type OTHER

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

Interventions

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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.

Intervention Type PROCEDURE

Axillary surgery

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

Intervention Type PROCEDURE

Titanium marker

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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Suros Surgical (now Hologic )

UNKNOWN

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Marie Ganott

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 24649373 (View on PubMed)

Other Identifiers

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PRO07100450

Identifier Type: -

Identifier Source: org_study_id