Automated Breast Ultrasound Case Collection Registry

Breast Cancer Clinical Trial

Official title:

Automated Breast Ultrasound Case Collection Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03417024
• Other study ID #: 110.01-2016-GES-0001
• Status: Terminated
• Start date: July 12, 2018
• Est. completion date: January 25, 2019

Study information

• Verified date: July 2019
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: January 25, 2019
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Complete Breast Imaging Datasets		Up to 6 Years
Secondary	Type of Exams Performed Per Patient		Up to 6 years
Secondary	Breast Cancer Status		Up to 6 years