Working… Menu

Accuracy of FNA Versus CNB of Abnormal Axillary Lymph Nodes in Setting of Invasive Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02019303
Recruitment Status : Active, not recruiting
First Posted : December 24, 2013
Last Update Posted : January 30, 2020
Huntsman Cancer Institute
Information provided by (Responsible Party):
Nicole Winkler, University of Utah

Brief Summary:

To compare accuracy of ultrasound guided fine needle aspiration (FNA) to core needle biopsy (CNB) of ultrasound detected abnormal axillary lymph nodes in patients with newly diagnosed invasive breast cancer or suspected invasive breast cancer.

Hypothesis: FNA and CNB have equivalent diagnostic accuracies

In order to prove our hypothesis, we will perform FNA and CNB on the same lymph node in each consented patient. The two samples will be evaluated separately by different pathologists blinded to the material in the other sample.

The results of the biopsies will be compared to the gold standard (lymph node excision).

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: FNA and Core biopsy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
Official Title: Ultrasound Guided Core Needle Biopsy Versus Fine Needle Aspiration of Morphologically Abnormal Axillary Lymph Node in Patients With New Diagnosis or Suspected Diagnosis of Invasive Breast Carcinoma
Actual Study Start Date : February 2014
Actual Primary Completion Date : August 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Abnormal lymph nodes
There is only one arm to this study and includes all eligible and consented patients with abnormal axillary lymph node on ultrasound.
Procedure: FNA and Core biopsy
Both procedures will be performed on the same lymph node

Primary Outcome Measures :
  1. Accuracy of FNA and CNB [ Time Frame: 2 years ]
    Accuracy will be determined by comparing the results of the FNA and CNB performed on the same lymph node to the gold standard using a paired test of equivalence. The gold standard is the final pathologic diagnosis of excised lymph node containing biopsy marker (either sentinel lymph node biopsy or axillary dissection). Surgical excision of pre-operatively sampled lymph node marks the end of study participation for each patient.

Secondary Outcome Measures :
  1. Pain associated with FNA and CNB [ Time Frame: 2 years ]
    Pain associated with each biopsy method will be assessed with a visual analog scale (0- 10) after a baseline pain measurement. The results will be compared to baseline pain level and analyzed using a paired t test.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Recent or suspected diagnosis of invasive breast cancer with abnormal ipsilateral axillary lymph node
  • Able to provide informed consent

Exclusion Criteria:

  • Lymph node not amenable to core biopsy
  • Patient is unlikely to undergo lymph node excision (i.e. elderly patient with co-morbidities)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02019303

Layout table for location information
United States, Utah
Huntsman Cancer Hospital
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Huntsman Cancer Institute
Layout table for additonal information
Responsible Party: Nicole Winkler, M.D., University of Utah Identifier: NCT02019303    
Other Study ID Numbers: 00068472
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases