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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by GE Healthcare
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT02042456
First received: January 20, 2014
Last updated: April 24, 2014
Last verified: April 2014

January 20, 2014
April 24, 2014
April 2014
June 2017   (final data collection date for primary outcome measure)
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).
Abnomal 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).
Complete list of historical versions of study NCT02042456 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts
Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Breast Cancer
  • 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
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.
Interventions:
  • Device: Digital Breast Tomosynthesis
  • Device: Automated Whole Breast Ultrasound
  • Device: Full Field Digital Mammography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
650
June 2017
June 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
United States
 
NCT02042456
124.03-2013-GES-0003
No
GE Healthcare
GE Healthcare
Not Provided
Not Provided
GE Healthcare
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP