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

This study is not yet open for participant recruitment.
Verified January 2014 by GE Healthcare
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT02042456
First received: January 20, 2014
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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 Intervention
Breast Cancer
Device: Digital Breast Tomosynthesis
Device: Automated Whole Breast Ultrasound
Device: Full Field Digital Mammography

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Abnormal interpretation rate [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Abnormal interpretation rates for each modality (FFDM and DBT+V-Preview, with and without ABUS+V-Preview).


Secondary Outcome Measures:
  • Sensitivity [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Sensitivity will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS

  • Specificity [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Specificity will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS

  • Cancer Rate [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Cancer Rate will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS

  • Positive Predictive Value [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Positive Predictive Value will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS

  • Negative Predictive Value [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Negative Predictive Value will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS


Estimated Enrollment: 650
Study Start Date: January 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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; AND
  • At moderately increased or high risk (>15% lifetime risk) for breast cancer based on meeting one or more of the ACS criteria 1:

    1. BRCA1 or BRCA2 gene mutation;
    2. first-degree relative with BRCA1 or BRCA2 gene mutation (based on subject self-report) and have not had genetic testing themselves;
    3. radiation therapy to the chest between ages 10 and 30 years;
    4. Li-Fraumeni syndrome, Cowden syndrome, or Bannayan-Riley-Ruvalcaba syndrome, or one of these syndromes in a first-degree relative;
    5. previous diagnosis of breast cancer, ductal carcinoma in situ (DCIS), lobular carcinoma in situ, atypical ductal hyperplasia, or atypical lobular hyperplasia.

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 based on urine pregnancy test;*
  • Present with contraindications to any imaging examination required in the study protocol;
  • Have breast implants;
  • Are lactating.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02042456

Locations
United States, Washington
University of Washington Seattle Cancer Care Alliance Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Suzanne Kolb    206-288-6321    skolb@seattlecca.org   
Principal Investigator: Constance Lehman, MD         
Sub-Investigator: Janie Lee, MD         
Sub-Investigator: Christoph Lee, MD         
Sub-Investigator: Habibollah Rahbar, MD         
Sub-Investigator: John Scheel, MD         
Sponsors and Collaborators
GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT02042456     History of Changes
Other Study ID Numbers: 124.03-2013-GES-0003
Study First Received: January 20, 2014
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GE Healthcare:
breast cancer
dense breasts
mammography screening
Screening techniques
women

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 23, 2014