Breast 3DUS ABUS System Comparison

Sponsor

Western University, Canada (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06118996

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Diseases	Device: 3D Ultrasound Image Acquisition	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

May 1, 2024

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients at Risk of Breast Cancer These patients will be imagined with an experimental device designed to acquire ultrasound in three dimensional volumes	Device: 3D Ultrasound Image Acquisition A custom device will be used with a clinical ultrasound machine to acquire ultrasound images of the breast.

Arm

Intervention/Treatment

Experimental: Patients at Risk of Breast Cancer

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

Device: 3D Ultrasound Image Acquisition

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

Outcome Measures

Primary Outcome Measures

Breast Images [24 months]
Images of the breast anatomy will be compared to standard of care imaging.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Western University, Canada

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Western University, Canada

ClinicalTrials.gov Identifier:

NCT06118996

Other Study ID Numbers:

14144

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Western University, Canada

3D Ultrasound

Intervention

Additional relevant MeSH terms:

Breast Diseases

Study Results

No Results Posted as of Nov 7, 2023