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

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: FNA and Core biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02019303

00068472

Details and patient eligibility

About

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).

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

140 participants in 1 patient group

Abnormal lymph nodes

Other group

Description:

There is only one arm to this study and includes all eligible and consented patients with abnormal axillary lymph node on ultrasound.

Treatment:

Procedure: FNA and Core biopsy