Lesion Detection of Automated Breast Ultrasound Compared With Handheld Physician-performed Breast Ultrasound

Northwestern University

Status: Completed

Conditions: Breast Diseases

Treatments: Device: High-resolution handheld breast ultrasound; Device: Supine automated breast ultrasound scanner

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02310776

STU00043696

Details and patient eligibility

About

Compare lesion detection of the automated breast ultrasound (ABVS) exam with the conventional handheld (HH) breast ultrasound (US) exam.

Full description

This is a research study to test a FDA-approved automated breast ultrasound (ABVS) machine in subjects recommended for an ultrasound of the breast. The main purpose of the study is to compare images obtained from the automated breast ultrasound exam with the standard physician performed handheld breast ultrasound exam for lesion detection equivalence.

Each subject will have a bilateral hand-held breast ultrasound and a bilateral automated breast ultrasound, both exams preferably done on the same day. The hand-held ultrasound will be performed by a breast imaging physician participating in the study and the automated ultrasound exam will be performed by a sonographer.

There is no radiation risk from ultrasound. The physician performing the handheld breast ultrasound is blinded to the study, will not know the subject's history, but only the reason for the breast ultrasound exam.

The automated scan requires gentle pressure on the breast during a scan. Three basic views will be acquired for each breast, each scan lasting approximately one minute. Once all necessary views are acquired, the images will be sent to a remote workstation, where a second radiologist, also blinded to the results of the handheld study, will interpret the automated ultrasound.

Once all images and patient information are gathered, the study radiologists will review the previous images, if available, to provide the final result that will determine clinical management. Therefore, it is possible that the hand-held or automated ultrasound scan will lead to further evaluation of the breast and possibly a biopsy.

Enrollment: 501 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• anyone who is referred for an ultrasound of the breast

Exclusion criteria

• Subjects whose breast thickness is greater than 6 cm.The maximum depth of image filed for the ABVS acquisition is 6 cm

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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501 participants in 1 patient group

Automated & Handheld breast US exams

Other group

Description:

1. Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner. 2. Handheld breast ultrasound exam: High-resolution handheld breast ultrasound.

Treatment:

Device: High-resolution handheld breast ultrasound

Device: Supine automated breast ultrasound scanner