Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment

Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study

The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in combination with full field digital mammography (FFDM) has the potential to reduce significantly baseline screening recall rates without a loss in the detection of cancers. The primary hypothesis of the study is that DBT in combination with FFDM will reduce baseline screening mammography recall rates in negative examinations by at least 20%.

Study Overview

• Status: Completed
• Conditions: Breast Abnormalities
• Intervention / Treatment: Device: tomosynthesis and screening mammography

Detailed Description

The FFDM images and the FFDM images with the DBT images will be interpreted independently by two experienced radiologists under standard clinical screening procedures. Recommended recall rates will be assessed and compared as a result of each of the two interpretations.

• Study Type: Interventional
• Enrollment (Actual): 1080
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women between the ages of 34 and 56.
• Women presenting for their baseline screening mammography examination

Exclusion Criteria:

• Women with a palpable finding(s) via a Breast Self Examination (BSE) or Clinical Breast Examination (CBE).
• Women who may be or are pregnant by self report
• Women older than 55 years of age or younger than 35.
• Women with known fatty breast tissue
• Males and children
• Women who are unable to understand or execute written informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Without Cancer Who Were Recalled	Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.	upon recruitment/enrollment phase completion

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Jules H Sumkin, DO, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: April 16, 2010
• First Submitted That Met QC Criteria: April 19, 2010
• First Posted (ESTIMATE): April 20, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 25, 2016
• Last Update Submitted That Met QC Criteria: February 24, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: digital breast tomosynthesis; baseline screening mammography; recall rates
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: PRO09060334