3D Ultrasound for the Imaging of Axillary Lymph Nodes in Patients With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This early phase I studies how well a new 3D ultrasound (3D-US) imaging technology works in evaluating axillary lymph nodes in patients with breast cancer. Ultrasound uses high-frequency sound waves to generate images of the body.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. Conducting a pilot study to optimize the in vivo performance of the newly developed three-dimensional (3D)-ultrasound (US) technology. II. Evaluate the performance of the new 3D-US technique in differentiating benign from malignant axillary lymph nodes (ALNs). III. Compare the performance of the new 3D-US method with conventional two-dimensional (2D)-US for localizing the clipped ALNs. OUTLINE: Patients undergo 3D-US on study. Patients who have an ALN clip placed and undergoing neoadjuvant chemotherapy undergo imaging of the clipped node before surgery.

Official Title
-----------------
3D Ultrasound Imaging of the Axillary Lymph Nodes

Conditions
-----------------
Breast Carcinoma

Intervention / Treatment
-----------------
* Device: Ultrasound Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients with breast cancer and scheduled to have axillary lymph node biopsy as per routine clinical care. Age of 18 or older. Exclusion Criteria: Vulnerable subjects such as prisoners and adults lacking capacity to consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (3D-US)<br>Patients undergo 3D-US on study. Patients who have an ALN clip placed and undergoing neoadjuvant chemotherapy undergo imaging of the clipped node before surgery. | Device: Ultrasound Imaging<br>* Undergo 3D-US<br>* Other names: US;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axillary lymph node (ALN) diagnosis by radiologist (benign or malignant) (Aim 2) | Will characterize the ALN as benign or malignant by reviewing images from each imaging technique based on clinical criteria including node size, shape, margin, cortical thickness, stiffness, and vascularity obtained from B-mode, shear wave elastography, and Doppler imaging. Histopathology results will be used as the ground truth to measure the sensitivity and specificity of each ultrasound technology for distinguishing between benign and malignant ALNs. The overall agreement of the new 3dimensional (D)-ultrasound (US) method with the biopsy result will be compared to that for 2D-US using McNemar's test. For clipped ALNs, the performance of 2D and 3D-US will be compared for localizing the clips. A numerical score system will be used for quantifying the performance of clip localization, with significant improvement in scores determined using the Freeman-Halton extension of the Fisher exact test. In all cases, we will consider two-tailed p < 0.05 as statistically significant. | Up to 2 years |