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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02643966
Recruitment Status : Active, not recruiting
First Posted : December 31, 2015
Last Update Posted : April 4, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wendie Berg, University of Pittsburgh

Brief Summary:
The purpose of this study is to evaluate the role of technologist-performed whole breast ultrasound for detecting breast cancer in the screening population of women with dense breasts.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Whole breast ultrasound Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6356 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT (Also Known as "DBTUST-Dense Breast Tomosynthesis / Ultrasound Screening Trial")
Study Start Date : December 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Whole breast ultrasound
All women will receive both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation will vary for each of two radiologists
Device: Whole breast ultrasound
Breast cancer screening with whole breast ultrasound

Primary Outcome Measures :
  1. True positive and false positive findings of whole breast ultrasound and digital breast tomosynthesis confirmed by routine follow-up or pathology outcome. [ Time Frame: three years ]
  2. Number of women recalled for additional testing, short-interval follow-up, or biopsy based on whole breast ultrasound or digital breast tomosynthesis (3D mammography) [ Time Frame: within 2 weeks after screening ]

Secondary Outcome Measures :
  1. Type of abnormalities detected by whole breast ultrasound and digital breast tomosynthesis. [ Time Frame: three years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02643966

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United States, Pennsylvania
Weinstein Imaging Associates
Pittsburgh, Pennsylvania, United States, 15206
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Wendie Berg
National Cancer Institute (NCI)
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Principal Investigator: Wendie Berg, MD, PhD University of Pittsburgh

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Responsible Party: Wendie Berg, Professor of Radiology, University of Pittsburgh Identifier: NCT02643966    
Other Study ID Numbers: PRO14100275
R01CA187593-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Keywords provided by Wendie Berg, University of Pittsburgh:
whole breast ultrasound
digital breast tomosynthesis
breast density
breast cancer screening
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases