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

NCT02019303 | Completed DMC

• 1 other identifier: 00068472
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Accuracy of FNA and CNB

  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.

  2 years

Secondary Outcomes (1)

• Pain associated with FNA and CNB

  2 years

Study Arms (1)

Abnormal lymph nodes

OTHER

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

Interventions

FNA and Core biopsy PROCEDURE

Both procedures will be performed on the same lymph node

Abnormal lymph nodes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead
• Huntsman Cancer Institute: collaborator

Study Sites (1)

Huntsman Cancer Hospital

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy, Needle

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 24, 2013
• Study Start: February 1, 2014
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

US (1)