Breast Diseases
Conditions
Brief summary
Compare lesion detection of the automated breast ultrasound (ABVS) exam with the conventional handheld (HH) breast ultrasound (US) exam.
Detailed 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.
Interventions
DEVICESupine automated breast ultrasound scanner
Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.
DEVICEHigh-resolution handheld breast ultrasound
Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist
Sponsors
Siemens Medical Solutions
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Lesions Detected With Automated Breast Ultrasound (ABVS) Compared to the Standard of Care Handheld (HH) Breast Ultrasound (US) | 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. | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Automated & Handheld Beast US Exams 1. Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.
2. Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist | 501 |
| Total | 501 |
Baseline characteristics
| Characteristic | Automated & Handheld Beast US Exams |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 40 Participants |
| Age, Categorical Between 18 and 65 years | 461 Participants |
| Region of Enrollment United States | 501 participants |
| Sex: Female, Male Female | 501 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 501 |
| serious Total, serious adverse events | 0 / 501 |
Outcome results
Primary
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 frame: 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.
Population: Each participant was evaluated based on Breast Imaging-Reporting and Data System (BI-RADS) assessment for Automated and Handheld breast ultrasound exams. If participant had more than one lesion, each lesion was assessed and listed separately and if a participant did not have a lesion, she was entered once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Automated & Handheld Breast US Exams | Ratio of Lesions Detected With Automated Breast Ultrasound (ABVS) Compared to the Standard of Care Handheld (HH) Breast Ultrasound (US) | 1.19 Detection ratio of lesions |