Breast 3DUS ABUS System Comparison
- Conditions
- Breast Diseases
- Interventions
- Device: 3D Ultrasound Image Acquisition
- Registration Number
- NCT06118996
- Lead Sponsor
- Western University, Canada
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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).
- Patients with breast implants.
- Patients with contraindication for ABUS.
- Patients who cannot tolerate ABUS.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients at Risk of Breast Cancer 3D Ultrasound Image Acquisition These patients will be imagined with an experimental device designed to acquire ultrasound in three dimensional volumes
- Primary Outcome Measures
Name Time Method Breast Images 24 months Images of the breast anatomy will be compared to standard of care imaging.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
St. Joseph's Hospital
🇨🇦London, Ontario, Canada