Breast 3DUS ABUS System Comparison

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-18

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients at Risk of Breast Cancer

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

Group Type EXPERIMENTAL

3D Ultrasound Image Acquisition

Intervention Type DEVICE

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

Interventions

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3D Ultrasound Image Acquisition

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

Intervention Type DEVICE

Eligibility Criteria

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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).