Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT

This is a prospective study designed to evaluate the role of whole breast ultrasound (WBUS)
in screening for breast cancer. In particular, there is interest in investigating the value
of using WBUS as an adjunct (supplementary imaging) to Digital Breast Tomosynthesis (DBT)
based screening of women with dense (heterogeneously or extremely dense) breasts or as a
primary screening examination in this group of women. Women scheduled for their routine
mammography that includes a DBT exam who agree to participate in the study and sign informed
consent will undergo (at the same visit) DBT imaging as part of their clinical exam and whole
breast ultrasound (WBUS) each year for three rounds of screening plus one year of follow-up.
The DBT images and WBUS will be interpreted independently by two experienced radiologists
under standard clinical screening procedures. One radiologist will interpret the DBT and the
other radiologist will interpret the WBUS. Using a modified "LOGICAL OR" approach
women/subjects may be recalled for further diagnostic work-up (examinations). If a subject is
recalled, she will then follow the standard/routine clinical procedures for follow-up and the
investigators will verify outcomes. If neither radiologist recalls the subject, then the
subject will follow conventional management and the investigators will verify outcome. The
findings from the DBT and WBUS examinations, as well as any resulting follow-up, will be
collected, recorded and analyzed.

Inclusion Criteria:

- Women aged 40 to 75 years of age with 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 BRCA
mutation (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 or lactation within the prior 6 months;

- Plan to become pregnant in the next two years, as mammography is not typically
performed for screening pregnant women;

- 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;

- Prior or current malignancy other than the following: a) 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 b) Basal or squamous cell
skin cancer or in situ cervical cancer or stage I thyroid cancer; or c) 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.

- Screening contrast-enhanced MRI or 99mTc-sestamibi based imaging of the breast(s)
within the prior 12 months or planned within the next two years, to avoid
contamination of results;

- Unwilling or unable to provide consent.