Breast 3DUS ABUS System Comparison

April 9, 2025 updated by: Western University, Canada

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 24 months
Images of the breast anatomy will be compared to standard of care imaging.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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