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Whole Breast Ultrasound and Digital Tomosynthesis Mammography in Screening Women with Denser Breasts for Breast Cancer

Trial Status: Active

This clinical trial studies how well digital tomosynthesis mammography combined with whole breast ultrasound works in screening for breast cancer in women with denser breast tissue. Digital tomosynthesis mammography combined with whole breast ultrasound may improve early breast cancer detection in women with denser breasts and allow physicians to plan better treatment for breast cancer.

Inclusion Criteria

  • Women 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
  • For women who have not had any prior mammography (i.e. this is their first, baseline, mammogram), the breast tissue must be dense (heterogeneously dense or extremely dense) on the current mammogram

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
  • Prior mammogram (if any) more than 3 years ago
  • 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
  • Recent prior breast surgery or breast biopsy or cyst aspiration within the prior 12 months
  • Prior or current 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 stage I thyroid 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
  • Screening contrast-enhanced magnetic resonance imaging (MRI) or 99mTc-sestamibi based imaging of the breast(s) within the prior 12 months or planned within the next two years
  • Unwilling or unable to provide consent
  • Current routine mammogram has been/will be performed more than 8 weeks prior to scheduled screening ultrasound


University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Contact: Wendie A. Berg
Phone: 412-641-1635


I. The overriding aim is to perform a clinical study that would allow for assessing the performance of digital breast tomosynthesis (digital tomosynthesis mammography [DBT]) alone versus DBT plus whole breast ultrasound (WBUS), and potentially WBUS serving as a primary screening modality.

OUTLINE: Participants will undergo a yearly WBUS lasting approximately 20-30 minutes and yearly DBT for 3 years.

Trial Phase Phase NA

Trial Type Screening

Lead Organization
University of Pittsburgh Cancer Institute (UPCI)

Principal Investigator
Wendie A. Berg

  • Primary ID 17-083
  • Secondary IDs NCI-2017-01821, PRO14100275
  • ID NCT02643966