Breast 3DUS ABUS System Comparison

Breast Diseases Clinical Trial

Official title:

Comparing the Efficacy of 3D Ultrasound Imaging of Breast Pathology Between a Custom ITA Device and Invenia™ ABUS System by GE Medical

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06118996
• Other study ID #: 14144
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Western University, Canada
• Contact: Anat Kornecki, MD
• Phone: 519-646-6100
• Email: Anat.Kornecki[@]sjhc.london.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Diseases

Intervention

Device:
• 3D Ultrasound Image Acquisition
A custom device will be used with a clinical ultrasound machine to acquire ultrasound images of the breast.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast Images	Images of the breast anatomy will be compared to standard of care imaging.	24 months