NCT03417024

Automated Breast Ultrasound Case Collection Registry

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-07-12
• Primary completion: 2019-01-25
• Completion: 2019-01-25
• First posted: 2018-01-31
• Last updated: 2019-09-09
• Results posted: 2019-09-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study