Back to resultsAssessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment
Primary Purpose
Breast Abnormalities
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tomosynthesis and screening mammography
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Abnormalities focused on measuring digital breast tomosynthesis, baseline screening mammography, recall rates
Eligibility Criteria
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
Sites / Locations
- Magee-Womens Hospital
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01106911
First Posted
April 16, 2010
Last Updated
February 24, 2016
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT01106911
Brief Title
Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment
Official Title
Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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%.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Abnormalities
Keywords
digital breast tomosynthesis, baseline screening mammography, recall rates
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1080 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
tomosynthesis and screening mammography
Other Intervention Name(s)
digital breast tomosynthesis
Intervention Description
All eligible subjects will undergo both full field digital mammography and digital breast tomosynthesis.
Primary Outcome Measure Information:
Title
Number of Participants Without Cancer Who Were Recalled
Description
Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.
Time Frame
upon recruitment/enrollment phase completion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jules H Sumkin, DO
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment
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