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

Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT (Also Known as "DBTUST-Dense Breast Tomosynthesis / Ultrasound Screening Trial")

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 6266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital
    • Pittsburgh, Pennsylvania, United States, 15206
      • Weinstein Imaging Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer Yield Per 1,000	Results from the first radiologist observer are presented	3 Years
Sensitivity (True Positive Rate)	DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer	3 years
False-positive Recall Rate	DBT false-positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Types of Abnormalities Detected by Ultrasound and Tomosynthesis	Counts and percentages of participants diagnosed with cancer and detected by first observer with DBT only, DBT and WBUS, and WBUS only	3 years

Collaborators and Investigators

• Sponsor: Wendie Berg
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Wendie Berg, MD, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: December 23, 2015
• First Submitted That Met QC Criteria: December 30, 2015
• First Posted (Estimated): December 31, 2015

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer screening; breast density; digital breast tomosynthesis; whole breast ultrasound
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PRO14100275; R01CA187593-01A1 (U.S. NIH Grant/Contract)