NCT06118996

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Western University, Canada · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Diseases

Interventions

Type	Name	Description
DEVICE	3D Ultrasound Image Acquisition	A custom device will be used with a clinical ultrasound machine to acquire ultrasound images of the breast.

Timeline

• Start date: 2024-08-18
• Primary completion: 2026-04-01
• Completion: 2026-12-01
• First posted: 2023-11-07
• Last updated: 2025-04-13

Locations

1 site across 1 country: Canada