Breast 3DUS ABUS System Comparison

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.

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Key information

Conditions

Breast Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D Ultrasound Image Acquisition

Device

A custom device will be used with a clinical ultrasound machine to acquire ultrasound images of the breast.

Primary outcomes

Breast Images

Time frame: 24 months

Images of the breast anatomy will be compared to standard of care imaging.

Study contacts

Contact information is provided by the study sponsor or research team.

Anat Kornecki, MD

CONTACT

[email protected]

519-646-6100

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Nov 7, 2023
Registry last updated: Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting