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Brief Summary: The QT Ultrasound system is an automated scanner which transmits pulsed ultrasound plane waves through the breast, as well as collects reflected ultrasound output. As the patient lays prone on a table, the breast is submerged in a warm water bath. The transmitter and receiver assembly moves around the suspended breast to record data for successive sub-volumes of targeted tissue. More than 2000 elements in the curvilinear transducer's array encircle the breast to gather data from the tissue structures of the breast, from nipple to chest wall. Information gathered from this automated QT scan encompasses the entire breast which is currently not commercially available using any other ultrasound technology.
This is a prospective, multicenter, multi-arm case collection study, with IRB approval. The study will follow an adaptive design with an initially planned total enrollment of approximately 600 cases to include both benign and malignant cases, representative of all tissue densities.
The images and clinical data accrued in this prospective case collection will be used for creation of a database to facilitate future reader's studies, publications, building teaching files, and future marketing for QT Ultrasound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | The group of asymptomatic subjects who have been given BI-RADS 1 or 2 based on their most recent standard of care assessment. All subjects will receive a QT Ultrasound scan. |
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| Cohort B | The group of asymptomatic women who have been given BI-RADS categories 4 or 4a, 4b, 4c or 5 based on their most recent standard of care assessment. All subjects will receive a QT Ultrasound scan. |
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| Cohort C | The group of women who have been given BI-RADS categories 1, 2, 3, 4 or (4a, 4b, 4c), 5 or 6 based on their most recent standard of care assessment. All subjects will receive a QT Ultrasound scan. Subjects are assigned to Cohort C when it has been determined they cannot be assigned to Cohort A or Cohort B. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QT Ultrasound scan | Device | QT Ultrasound scan |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of QT Ultrasound to DM-DBT | Non-inferiority evaluation of sensitivity, specificity, positive predictive value and non-cancer recall rate. | 12 months |
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INCLUSION CRITERIA All Subjects
Cohort A and B Subjects that do not meet these Inclusion Criteria will be evaluated for Inclusion in Cohort C
Cohort C
1. Willing and able to submit available breast imaging - for one or both breasts, before or after, their QT scan.
EXCLUSION CRITERIA All Subjects
Cohort A and B Subjects that meet any of these conditions below will not be eligible for Cohort A or B and will be evaluated for eligibility in Cohort C.
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Women, age 18 and older
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Care Long Beach | Long Beach | California | 90806 | United States | ||
| Marin Breast Health Trial Center |
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| Novato |
| California |
| 94949 |
| United States |