NCT05704283

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

3D Ultrasound Imaging of the Axillary Lymph Nodes

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This early phase I studies how well a new 3D ultrasound (3D-US) imaging technology works in evaluating 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 lymph nodes in patients. III. Compare the performance of the new 3D-US method with conventional two-dimensional (2D)-US for localizing the clipped lymph nodes. OUTLINE: Patients undergo 3D-US on study. Patients who have a lymph node clip placed and undergoing neoadjuvant chemotherapy undergo imaging of the clipped node before surgery.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
DEVICE	Ultrasound Imaging	Undergo 3D-US

Timeline

• Start date: 2023-02-14
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2023-01-30
• Last updated: 2025-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study