Automated Breast Ultrasound Case Collection Registry

General Electric (GE)

Status: Terminated

Conditions: Breast Cancer

Treatments: Device: Digital Breast Tomosynthesis; Device: Automated Breast Ultrasound

Study type: Observational

Funder types: Industry

Identifiers

NCT03417024

110.01-2016-GES-0001

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

13 participants in 1 patient group

All Subjects

Description:

All subjects will undergo scanning with both Automated Breast Ultrasound and Digital Breast Tomosynthesis devices.

Treatment:

Device: Digital Breast Tomosynthesis

Device: Automated Breast Ultrasound