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Completed

NCT Number: NCT02019303

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

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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huntsman Cancer Hospital

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FNA and Core biopsy

Procedure

Both procedures will be performed on the same lymph node

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Huntsman Cancer Institute

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 24, 2013
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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