Actively Recruiting
Comparing the Efficacy of 3D Ultrasound Imaging of Breast Pathology Between a Custom ITA Device and Invenia™ ABUS System by GE Medical
Led by Western University, Canada · Updated on 2025-04-13
30
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a custom 3-dimensional ultrasound device designed to image breast pathology compared to the commercial InveniaTM ABUS system by GE Medical. This study focuses on females scheduled for mammography and ultrasound assessments to see how well the new 3D ultrasound device can visualize tumors and important breast features. Participants will undergo routine 2D ultrasound imaging as part of their clinical care, and during the study, additional 3D ultrasound images will be acquired using a specialized device developed by the ultrasound imaging laboratory at Western University. This custom device is used along with a clinical ultrasound machine to capture detailed three-dimensional volumes of the breast. During the study, participants will have both standard and research ultrasound imaging performed. Researchers will collect breast images over a 24-month period to compare the quality and detail of images from the custom device and the InveniaTM system. This process will help assess how well the new device identifies breast abnormalities and tumors. The total participation duration and monitoring details depend on the imaging schedule during this time.
CONDITIONS
Brief Title
Breast 3DUS ABUS System Comparison
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients who are scheduled for screening ABUS
- Adult 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)
You will not qualify if you...
- Patients with breast implants
- Patients with contraindication for ABUS
- Patients who cannot tolerate ABUS
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 months
Participants undergo breast imaging using a custom 3D ultrasound device alongside the standard ABUS system.
Imaging visits as scheduled during the 24 months
Trial Site Locations
Total: 1 location
1
St. Joseph's Hospital
London, Ontario, Canada, N6A 4V2
Actively Recruiting
Research Team
A
Anat Kornecki, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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