We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT02042456
Recruitment Status : Terminated (Change in study staff at the site, change in Sponsor direction)
First Posted : January 22, 2014
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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

Condition or disease Intervention/treatment
Breast Cancer Device: Digital Breast Tomosynthesis Device: Automated Whole Breast Ultrasound Device: Full Field Digital Mammography

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 124 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts
Study Start Date : April 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: Digital Breast Tomosynthesis
digital breast tomosynthesis technology
Other Name: GE SenoClaire DBT with V-Preview

Device: Automated Whole Breast Ultrasound
Automated Whole Breast Ultrasound
Other Name: Invenia ABUS

Device: Full Field Digital Mammography


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Abnormal interpretation rate [ Time Frame: One Year ]
    Abnormal interpretation rates for each modality (FFDM and DBT+V-Preview, with and without ABUS+V-Preview).


Secondary Outcome Measures :
  1. Sensitivity [ Time Frame: One Year ]
    Sensitivity will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS

  2. Specificity [ Time Frame: One Year ]
    Specificity will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS

  3. Cancer Rate [ Time Frame: One Year ]
    Cancer Rate will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS

  4. 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

  5. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
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
Subjects will be selected from the patients arriving at the clinic for yearly breast cancer screening exams
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT02042456


Locations
Layout table for location information
United States, Washington
University of Washington Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
GE Healthcare
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT02042456    
Other Study ID Numbers: 124.03-2013-GES-0003
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015
Keywords provided by GE Healthcare:
breast cancer
dense breasts
mammography screening
Screening techniques
women
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases