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

Mayo Clinic

Status and phase: Enrolling; Early Phase 1

Conditions: Breast Carcinoma

Treatments: Device: Ultrasound Imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05704283

22-006606

NCI-2023-00106 (Registry Identifier)

R01EB031040 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Diagnostic (3D-US)

Experimental group

Description:

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.

Treatment:

Device: Ultrasound Imaging