Recruiting • Phase O • Stage 0, I, II, III, IV • Post-Menopausal • Interventional

The following is imported from ClinicalTrials.gov:

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

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.

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.

Study Design

Eligibility Criteria

Arms and Intervention

• Ultrasound Imaging

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.