Automated Breast Ultrasound Case Collection Registry

NCT03417024 | Terminated Results FDA Device

• 1 other identifier: 110.01-2016-GES-0001
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Complete Breast Imaging Datasets

  Up to 6 Years

Secondary Outcomes (2)

• Type of Exams Performed Per Patient

  Up to 6 years

• Breast Cancer Status

  Up to 6 years

Study Arms (1)

All Subjects

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

Device: Automated Breast Ultrasound; Device: Digital Breast Tomosynthesis

Interventions

Automated Breast Ultrasound 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.

All Subjects

Digital Breast Tomosynthesis DEVICE

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

All Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll adult women with dense breasts clinically referred for breast cancer screening.

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.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Sr. Clinical Affairs Project Manager
• Organization: GE Healthcare

kevin.r.siewert@ge.com

2624095722

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: January 31, 2018
• Study Start: July 12, 2018
• Primary Completion: January 25, 2019
• Study Completion: January 25, 2019
• Last Updated: September 9, 2019
• Results First Posted: September 9, 2019

Record last verified: 2019-07

Locations

US (1)