Breast 3DUS ABUS System Comparison

Comparing the Efficacy of 3D Ultrasound Imaging of Breast Pathology Between a Custom ITA Device and Invenia™ ABUS System by GE Medical

This comparative study will recruit 30 females who are scheduled for mammography and ultrasound assessment. The clinical 2D ultrasound is performed routinely, and the research portion of this study will add a few extra 3-D ultrasound images during the procedure. The ultrasound imaging laboratory under the direction of Dr. Aaron Fenster has developed a customized device designed to acquire 3D ultrasound of the breast using a commercial ultrasound machine. The purpose is to see how well 3-dimensional ultrasound acquire from that device is able to visualize tumours and other key features in comparison to the clinical system InveniaTM developed by GE Medical.

Study Overview

• Status: Recruiting
• Conditions: Breast Diseases
• Intervention / Treatment: Device: 3D Ultrasound Image Acquisition

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anat Kornecki, MD; Phone Number: 519-646-6100; Email: Anat.Kornecki@sjhc.london.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • Recruiting
      • St. Joseph's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult Patients who are scheduled for screening ABUS
• Adults Patients who are scheduled for short term follow-up with ABUS.
• Must be at least 18 years of age or older.
• Must be proficient in English (reading/writing).

Exclusion Criteria:

• Patients with breast implants.
• Patients with contraindication for ABUS.
• Patients who cannot tolerate ABUS.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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: Patients at Risk of Breast Cancer; These patients will be imagined with an experimental device designed to acquire ultrasound in three dimensional volumes	Device: 3D Ultrasound Image Acquisition; A custom device will be used with a clinical ultrasound machine to acquire ultrasound images of the breast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast Images	Images of the breast anatomy will be compared to standard of care imaging.	24 months

Collaborators and Investigators

• Sponsor: Western University, Canada

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Intervention; 3D Ultrasound
• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases
• Other Study ID Numbers: 14144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No