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NCT05704283EARLY_PHASE1Recruiting

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

Mayo Clinic

Start Date

2/14/2023

Completion Date

6/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Patients with lymph node biopsy or lymph node clip placement as per routine clinical care. * Age of 18 or older. Exclusion Criteria: * Vulnerable subjects such as prisoners and adults lacking capacity to consent.

Interventions

DEVICE

Ultrasound Imaging

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Conditions

Breast Carcinoma

Locations

Mayo Clinic in Rochester

Rochester, Minnesota 55905

United States