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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: FNA and Core biopsy

• Registration Number: NCT02019303
• Lead Sponsor: 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-24
• Study Start: 2014-02
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Abnormal lymph nodes	FNA and Core biopsy	There is only one arm to this study and includes all eligible and consented patients with abnormal axillary lymph node on ultrasound.

Primary Outcome Measures

Name	Time	Method
Accuracy of FNA and CNB	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

Name	Time	Method
Pain associated with FNA and CNB	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.

Trial Locations

Locations (1)

Huntsman Cancer Hospital; 🇺🇸 Salt Lake City, Utah, United States