Recruiting

3DUS & ABUS

Sponsor:

Western University, Canada

Code:

NCT06118996

Conditions

Breast Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3D Ultrasound Image Acquisition

Study Details

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.

Conditions

Breast Diseases

Study ID

NCT06118996

Start date

Aug 18, 2024

Status verified date

Feb, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Patients at Risk of Breast Cancer

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

Interventions

3D Ultrasound Image Acquisition

A custom device will be used with a clinical ultrasound machine to acquire ultrasound images of the breast.

Primary outcome measure

  • Breast Images [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Anat Kornecki, MD

519-646-6100Anat.Kornecki@sjhc.london.on.ca

Locations

St. Joseph's Hospital

Recruiting

London, Ontario, Canada, N6A 4V2

More Information

Sponsor

Western University, Canada

Last update posted

Apr 13, 2025

Last verified

Feb, 2025

Keywords

  • 3D Ultrasound
  • Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2025-04-13.