Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts

October 16, 2015 updated by: GE Healthcare
This study is investigating whether automated whole breast ultrasound can improve detection of cancer in breast cancer screening when used as a supplement to mammography or as a supplement to digital breast tomosynthesis

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Subjects will be selected from the patients arriving at the clinic for yearly breast cancer screening exams

Description

Inclusion Criteria:

  • Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;
  • Women aged ≥18 years at the time of enrollment;*
  • Women with a previous determination of dense breasts determined by mammogram as heterogeneously dense or extremely dense;
  • At moderately increased or high risk (>15% lifetime risk) for breast cancer based on meeting one or more of the ACS criteria 1:

AND Referred for screening mammography

Exclusion Criteria:

  • Have been screened using any breast imaging technology in <12 months immediately prior to enrollment;
  • Exhibit breast cancer symptoms according to assessment by the subject's health care provider within one year prior to enrollment;
  • Diagnosed with breast cancer, with or without metastasis, within one year prior to enrollment;
  • Are currently pregnant as determined per standard clinical practice at the investigational site;
  • Present with contraindications to any imaging examination required in the study protocol;
  • Have breast implants; OR
  • Are lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Main Cohort
Subjects enrolled in this group will receive a full field digital mammogram, digital breast tomosynthesis exam and an automated whole breast ultrasound exam as part of their visit.
Device: Full Field Digital Mammography
Device: Digital Breast Tomosynthesis
digital breast tomosynthesis technology
Other Names:
  • GE SenoClaire DBT with V-Preview
Device: Automated Whole Breast Ultrasound
Automated Whole Breast Ultrasound
Other Names:
  • Invenia ABUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abnormal interpretation rate
Time Frame: One Year
Abnormal interpretation rates for each modality (FFDM and DBT+V-Preview, with and without ABUS+V-Preview).
One Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: One Year
Sensitivity will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS
One Year
Specificity
Time Frame: One Year
Specificity will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS
One Year
Cancer Rate
Time Frame: One Year
Cancer Rate will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS
One Year
Positive Predictive Value
Time Frame: One Year
Positive Predictive Value will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS
One Year
Negative Predictive Value
Time Frame: One Year
Negative Predictive Value will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GE Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (Estimate)

January 22, 2014

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 16, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 124.03-2013-GES-0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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