Assessment of Automated Breast Ultrasound

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.).

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Known to be at high risk for breast cancer due to known or suspected pathologic breast
cancer susceptibility gene (BRCA) (i.e. first-degree relative with known mutation) or
prior chest radiation therapy before age 30;

- No mammogram within the prior 3 years;

- Signs or symptoms of breast disease including lump, bloody or spontaneous clear nipple
discharge, eczema of the nipple;

- Pregnancy at the time of screening by self report or lactation within the prior 6
months;

- Breast implants, as assessment of breast density may be problematic;

- Recent prior breast surgery or breast biopsy or cyst aspiration within the prior 12
months;

- Had prior screening with DBT and not a hand held ABUS, or had prior screening with
ABUS and not DBT.

- Prior malignancy other than: Breast cancer at least one year earlier (12 full months
have elapsed since the last treatment surgery) with no known distant metastases and no
known residual tumor, or Basal or squamous cell skin cancer or in situ cervical
cancer, or Other cancer for which the patient has been disease free for ≥ 5 years,
with no recurrence of cancer in the last five years and no residual disease detected
in the last five years

- Unwilling or unable to provide consent.