Automated Breast Ultrasound Case Collection Registry
| Status: | Terminated |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/8/2019 |
| Start Date: | July 12, 2018 |
| End Date: | January 25, 2019 |
The contribution of automated breast ultrasound (ABUS) to the screening pathway for breast
cancer is not fully understood. This prospective study aims to collect longitudinal data in
women with dense breasts undergoing ABUS as a supplement to digital breast tomosynthesis
(DBT). The data are intended for use in future research on the value and effectiveness of
ABUS in routine clinical care.
Data will be collected from eligible women who have been prescribed or have completed DBT and
ABUS, screening within a 30-day window. Radiologist evaluations and, when performed, outcomes
of biopsy and/or laboratory testing will be recorded. Subjects will be followed for breast
cancer status and results of any diagnostic breast exams and/or treatment.
cancer is not fully understood. This prospective study aims to collect longitudinal data in
women with dense breasts undergoing ABUS as a supplement to digital breast tomosynthesis
(DBT). The data are intended for use in future research on the value and effectiveness of
ABUS in routine clinical care.
Data will be collected from eligible women who have been prescribed or have completed DBT and
ABUS, screening within a 30-day window. Radiologist evaluations and, when performed, outcomes
of biopsy and/or laboratory testing will be recorded. Subjects will be followed for breast
cancer status and results of any diagnostic breast exams and/or treatment.
Inclusion Criteria:
1. Are asymptomatic adult women (aged 18 years or older);
2. Are eligible to complete or have completed (within 30 days) screening ABUS and DBT
exams per the site standard of care;1
3. Have heterogeneously dense and extremely dense breasts (BI-RADS C or D, respectively)
or are determined to have dense breasts prior to the study on initial screening
mammography;
4. Are able and willing to participate.
Exclusion Criteria:
1. Have a breast cancer diagnosis (with or without metastasis) or are being treated for
breast cancer within the year prior to the study.
We found this trial at
1
site
5801 South Ellis Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
773.702.1234
Principal Investigator: David Schacht, MD, MPH
Phone: 773-702-2777
University of Chicago One of the world's premier academic and research institutions, the University of...
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