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

3D Ultrasound Imaging of the Axillary Lymph Nodes

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Carcinoma
• Intervention / Treatment: Device: Ultrasound Imaging

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 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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Shigao D. Chen, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (3D-US); 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.	Device: Ultrasound Imaging; Undergo 3D-US; Other Names: Ultrasound; 2-Dimensional Grayscale Ultrasound Imaging; 2-Dimensional Ultrasound Imaging; 2D-US; Ultrasound Test; Ultrasound, Medical; US; Ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axillary lymph node (ALN) diagnosis by radiologist (benign or malignant) (Aim 2)	Will characterize the ALN 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 the sensitivity and specificity of each ultrasound technology for distinguishing between benign and malignant ALNs. 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 ALNs, the performance of 2D and 3D-US will be compared for localizing the clips. A numerical score system will be used for quantifying the performance of clip localization, with significant improvement in scores determined using the Freeman-Halton extension of the Fisher exact test. In all cases, we will consider two-tailed p < 0.05 as statistically significant.	Up to 2 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI); National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Investigators: Principal Investigator: Shigao D Chen, Ph.D., Mayo Clinic in Rochester

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 22-006606; P30CA015083 (U.S. NIH Grant/Contract); NCI-2023-00106 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01EB031040 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes