Automated Breast Ultrasound Case Collection Registry
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|ClinicalTrials.gov Identifier: NCT03417024|
Recruitment Status : Terminated (Change in business strategy)
First Posted : January 31, 2018
Results First Posted : September 9, 2019
Last Update Posted : September 9, 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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Device: Automated Breast Ultrasound Device: Digital Breast Tomosynthesis|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||13 participants|
|Target Follow-Up Duration:||30 Months|
|Official Title:||Automated Breast Ultrasound Case Collection Registry|
|Actual Study Start Date :||July 12, 2018|
|Actual Primary Completion Date :||January 25, 2019|
|Actual Study Completion Date :||January 25, 2019|
All subjects will undergo scanning with both Automated Breast Ultrasound and Digital Breast Tomosynthesis devices.
Device: Automated Breast Ultrasound
The ABUS system is designed to methodically scan a breast and capture multiple ultrasound images that can be rendered and reviewed in three dimensions.
Device: Digital Breast Tomosynthesis
Digital Breast Tomosynthesis (DBT) systems are designed to collect 3-dimensional x-ray images of breast tissues.
- Number of Complete Breast Imaging Datasets [ Time Frame: Up to 6 Years ]
- Type of Exams Performed Per Patient [ Time Frame: Up to 6 years ]
- Breast Cancer Status [ Time Frame: Up to 6 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417024
|United States, Illinois|
|The University of Chicago|
|Chicago, Illinois, United States, 60637|