Breast 3DUS ABUS System Comparison

Western University, Canada

Status: Enrolling

Conditions: Breast Diseases

Treatments: Device: 3D Ultrasound Image Acquisition

Study type: Interventional

Funder types: Other

Identifiers

NCT06118996

14144

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Patients at Risk of Breast Cancer

Experimental group

Description:

These patients will be imagined with an experimental device designed to acquire ultrasound in three dimensional volumes

Treatment:

Device: 3D Ultrasound Image Acquisition