We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified January 2017 by Wendie Berg, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT02643966
First Posted: December 31, 2015
Last Update Posted: January 26, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wendie Berg, University of Pittsburgh
  Purpose
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 Intervention
Breast Cancer Device: Whole breast ultrasound

Study Type: Interventional
Study Design: 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")

Resource links provided by NLM:


Further study details as provided by Wendie Berg, University of Pittsburgh:

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

Estimated Enrollment: 6200
Study Start Date: December 2015
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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.


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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02643966


Contacts
Contact: Nicole Lettiere 412.641.8283 lettieren@mail.magee.edu

Locations
United States, Pennsylvania
Weinstein Imaging Associates Recruiting
Pittsburgh, Pennsylvania, United States, 15206
Contact: Marcela Velez, MD    412-441-1161    bohmvelez@weinsteinimaging.com   
Contact: Christine Kohut    412-440-6999    kohut@weinsteinimaging.com   
Magee-Womens Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Nicole Lettiere    412-641-8283    lettieren@mail.magee.edu   
Contact: Amy Kosanovic    412-641-8278    kosanovicam@mail.magee.edu   
Principal Investigator: Wendie Berg, MD, PhD         
Sponsors and Collaborators
University of Pittsburgh
National Cancer Institute (NCI)
Investigators
Principal Investigator: Wendie Berg, MD, PhD University of Pittsburgh
  More Information

Responsible Party: Wendie Berg, Professor of Radiology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02643966     History of Changes
Other Study ID Numbers: PRO14100275
R01CA187593-01A1 ( U.S. NIH Grant/Contract )
First Submitted: December 23, 2015
First Posted: December 31, 2015
Last Update Posted: January 26, 2017
Last Verified: January 2017

Keywords provided by Wendie Berg, University of Pittsburgh:
whole breast ultrasound
digital breast tomosynthesis
breast density
breast cancer screening