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Automated Breast Ultrasound Case Collection Registry

NCT03417024 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2019-09-09

Study results available
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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

Interventions

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.

DEVICE

Digital Breast Tomosynthesis

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

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-12
Primary Completion
2019-01-25
Completion
2019-01-25
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03417024 on ClinicalTrials.gov