Breast 3DUS ABUS System Comparison

NCT06118996 | Recruiting

• 1 other identifier: 14144
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

3D Ultrasound; Intervention

Outcome Measures

Primary Outcomes (1)

• Breast Images

  Images of the breast anatomy will be compared to standard of care imaging.

  24 months

Study Arms (1)

Patients at Risk of Breast Cancer

EXPERIMENTAL

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

Device: 3D Ultrasound Image Acquisition

Interventions

3D Ultrasound Image Acquisition DEVICE

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

Patients at Risk of Breast Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Patients with breast implants.
• Patients with contraindication for ABUS.
• Patients who cannot tolerate ABUS.

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

RECRUITING

MeSH Terms

Conditions

Breast Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Anat Kornecki, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: August 18, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)