Automated Breast Ultrasound Case Collection Registry

NCT ID: NCT03417024

Last Updated: 2019-09-09

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2019-01-25

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All Subjects

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

Automated Breast Ultrasound

Intervention Type: DEVICE

The ABUS system is designed to methodically scan a breast and capture multiple ultrasound images that can be rendered and reviewed in three dimensions.

Digital Breast Tomosynthesis

Intervention Type: DEVICE

Digital Breast Tomosynthesis (DBT) systems are designed to collect 3-dimensional x-ray images of breast tissues.

Interventions

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.

Intervention Type: DEVICE

Digital Breast Tomosynthesis

Digital Breast Tomosynthesis (DBT) systems are designed to collect 3-dimensional x-ray images of breast tissues.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Chicago

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

110.01-2016-GES-0001

Identifier Type: -

Identifier Source: org_study_id