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Automated Breast Ultrasound Case Collection Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03417024
Recruitment Status : Terminated (Change in business strategy)
First Posted : January 31, 2018
Results First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Breast Cancer Device: Automated Breast Ultrasound Device: Digital Breast Tomosynthesis

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Study Type : Observational [Patient Registry]
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Months
Official Title: Automated Breast Ultrasound Case Collection Registry
Actual Study Start Date : July 12, 2018
Actual Primary Completion Date : January 25, 2019
Actual Study Completion Date : January 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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

Primary Outcome Measures :
  1. Number of Complete Breast Imaging Datasets [ Time Frame: Up to 6 Years ]

Secondary Outcome Measures :
  1. Type of Exams Performed Per Patient [ Time Frame: Up to 6 years ]
  2. Breast Cancer Status [ Time Frame: Up to 6 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will enroll adult women with dense breasts clinically referred for breast cancer screening.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03417024

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United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
GE Healthcare
  Study Documents (Full-Text)

Documents provided by GE Healthcare:
Study Protocol  [PDF] January 9, 2018
No Statistical Analysis Plan (SAP) exists for this study.

Additional Information:

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Responsible Party: GE Healthcare Identifier: NCT03417024    
Other Study ID Numbers: 110.01-2016-GES-0001
First Posted: January 31, 2018    Key Record Dates
Results First Posted: September 9, 2019
Last Update Posted: September 9, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No