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

Early Phase 1

Recruiting

• Conditions: Breast Carcinoma
• Interventions: Device: Ultrasound Imaging

• Registration Number: NCT05704283
• Lead Sponsor: Mayo Clinic

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-30
• Study Start: 2023-02-14
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Patients with lymph node biopsy or lymph node clip placement as per routine clinical care.
• Age of 18 or older.

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Exclusion Criteria

• Vulnerable subjects such as prisoners and adults lacking capacity to consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (3D-US)	Ultrasound Imaging	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.

Primary Outcome Measures

Name	Time	Method
Lymph node diagnosis by radiologist (benign or malignant) (Aim 2)	Up to 2 years	Will characterize the lymph node 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 sensitivity and specificity of each ultrasound technology for distinguishing between benign and malignant lymph nodes. 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 lymph nodes, the performance of 2D and 3D-US will be compared for localizing the clips.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States