Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Siemens Medical Solutions | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Compare lesion detection of the automated breast ultrasound (ABVS) exam with the conventional handheld (HH) breast ultrasound (US) exam.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automated & Handheld breast US exams | Other |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supine automated breast ultrasound scanner | Device | Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist. |
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ellen B Mendelson, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medicine | Chicago | Illinois | 60611 | United States | ||
| Weinstein Imaging |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Automated & Handheld Breast US Exams |
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| High-resolution handheld breast ultrasound | Device | Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist |
|
| Pittsburgh |
| Pennsylvania |
| 15206 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Automated & Handheld Beast US Exams |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Number | 95% Confidence Interval | Detection ratio of lesions | 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. | Lesions | Participants |
|
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Automated & Handheld Breast US Exams |
| 0 | 501 | 0 | 501 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen B. Mendelson, MD, FACR, Lee F. Rogers Professor of Medical Education in Radiology, Profess | Northwestern Medicine | 3124720436 | emendels@nm.org |
| ID | Term |
|---|---|
| D001941 | Breast Diseases |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided