Automated Breast Ultrasound Case Collection Registry

Terminated

• Conditions: Breast Cancer
• Interventions: Device: Automated Breast Ultrasound; Device: Digital Breast Tomosynthesis

• Registration Number: NCT03417024
• Lead Sponsor: GE Healthcare

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-31
• Study Start: 2018-07-12
• Primary Completion: 2019-01-25
• Study Completion: 2019-01-25
• Status Verified: 2019-07
• Results First Submitted: 2019-07-31
• Results First Submitted QC: 2019-07-31
• Last Update Submitted: 2019-07-31
• Results First Posted: 2019-09-09
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 13

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Subjects	Automated Breast Ultrasound	All subjects will undergo scanning with both Automated Breast Ultrasound and Digital Breast Tomosynthesis devices.
All Subjects	Digital Breast Tomosynthesis	All subjects will undergo scanning with both Automated Breast Ultrasound and Digital Breast Tomosynthesis devices.

Primary Outcome Measures

Name	Time	Method
Number of Complete Breast Imaging Datasets	Up to 6 Years

Secondary Outcome Measures

Name	Time	Method
Type of Exams Performed Per Patient	Up to 6 years
Breast Cancer Status	Up to 6 years

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States