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

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

Detailed Description
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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.

Official Title
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Breast Lesion Detection Using the Acuson S2000 Automated Breast Volume Scanner (ABVS) Compared With Handheld (HH) Physician-performed Ultrasound (US) Examinations

Conditions
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Breast Diseases

Intervention / Treatment
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* Device: Supine automated breast ultrasound scanner
* Device: High-resolution handheld breast ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Automated & Handheld breast US exams<br>Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner. Handheld breast ultrasound exam: High-resolution handheld breast ultrasound. | Device: Supine automated breast ultrasound scanner<br>* Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.<br>Device: High-resolution handheld breast ultrasound<br>* Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of Lesions Detected With Automated Breast Ultrasound (ABVS) Compared to the Standard of Care Handheld (HH) Breast Ultrasound (US) | Solid lesions found on whole breast 3D supine automated breast ultrasound are compared in number and identity with solid lesions found using high resolution standard of care handheld breast ultrasound performed by physicians | Time for performance of ABVS was measured separately from interpretation time. Time for performance of real time HH whole breast US was also measured. For HH US physician performed, performance included interpretation. |