Automated Breast Ultrasound Case Collection Registry

Stopped early

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT03417024

Run by

GE Healthcare

People needed

13

Starts

2018-07-12

Expected to finish

2019-01-25

Last updated by the study team

2019-09-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Are asymptomatic adult women (aged 18 years or older);
• Are eligible to complete or have completed (within 30 days) screening ABUS and DBT exams per the site standard of care;1
• 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;
• Are able and willing to participate.

You may not qualify if…

• Have a breast cancer diagnosis (with or without metastasis) or are being treated for breast cancer within the year prior to the study.

Where it is running

• The University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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