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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06118996
Enrollment
30
Registered
2023-11-07
Start date
2024-08-18
Completion date
2026-12-31
Last updated
2025-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Diseases

Keywords

3D Ultrasound, Intervention

Brief summary

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.

Interventions

DEVICE3D Ultrasound Image Acquisition

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

Sponsors

Western University, Canada
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Breast Images24 monthsImages of the breast anatomy will be compared to standard of care imaging.

Countries

Canada

Contacts

Primary ContactAnat Kornecki, MD
Anat.Kornecki@sjhc.london.on.ca519-646-6100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026