Assessment of Automated Breast Ultrasound
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The investigators are interested in assessing the value of and comparing the use of automated
      breast ultrasound (ABUS) (either as a primary screening approach or as a supplementary
      procedure) with digital breast tomosynthesis (DBT). The purpose of this project is to perform
      a preliminary prospective study on women who are most likely to benefit from the use of ABUS
      and/or DBT (or a combination of both) in the screening environment.
    

Detailed description: 
      1. After appropriate training and certification of technologists and Mammography Quality
           Standards Act (MQSA) qualifications of the participating radiologists, the investigators
           will recruit sequentially approximately 600 women known to have a defined region of
           highly dense tissue or with known heterogeneously dense and/or primarily dense breast
           tissue (from a prior mammogram) who are scheduled to undergo routine mammography
           screening that includes a DBT examination.

        2. Consenting women will undergo a DBT examination as part of their routine clinical exam
           and an ABUS examination as a part of the experiment. All examinations will be performed
           by certified technologists in the performance of each of the procedures in question (DBT
           or ABUS).

        3. DBT, ABUS, and a combination of both, will be independently reviewed and interpreted
           (Breast Imaging, Reporting and Data System rated) by experienced and specifically
           trained, MQSA qualified radiologists in a cross balanced (cases by mode and by reader)
           study design.

        4. Using the results of the interpretations in a slightly modified "LOGICAL OR" mode,
           namely the highest rating determines the recommendation/need for follow up, the
           investigators will perform imaging based diagnostic work ups as needed (i.e., resulting
           from the "arbitration step"). All diagnostic follow up studies, as needed, will not be a
           part of the study protocol, with the exception of acquiring diagnostic outcome measures
           from medical records.

        5. The investigators will compare rates of false positives as a result of interpreting DBT
           vs. ABUS vs. a combination of both, including recall for additional testing,
           short-interval follow-up rates and biopsy rates. The sample in this preliminary study is
           too small to assess positive predictive values (PPVs), so the investigators will focus
           here on negative predictive values (NPVs). For marginal value assessment when utilizing
           both modalities, the investigators will also assess the type of abnormalities detected
           by each modality, assuming that a larger study will be required to assess cancer
           detection rates (by type etc.).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women aged 40 to 75 years of age with a defined region of extremely dense breast tissue or
        heterogeneously dense or extremely dense parenchyma by prior digital mammography report
        (i.e., "dense breasts"), presenting for routine annual mammography with digital breast
        tomosynthesis.