Status:
COMPLETED
Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates
Lead Sponsor:
American College of Radiology
Collaborating Sponsors:
Pennsylvania Department of Health
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
25+ years
Phase:
NA
Brief Summary
This multicenter trial using Hologic digital mammography units will evaluate the specificity of 2-D full field digital mammography (FFDM) versus a combination of 2-D and 3-D tomosynthesis imaging in b...
Detailed Description
Asymptomatic women 25 years and older with no history of breast cancer will be recruited from a prospective population of patients scheduled for screening mammography (Group A). A similar population o...
Eligibility Criteria
Inclusion
- Women 25 years of age or older;
- No history of breast cancer;
- Group A only: Asymptomatic and scheduled for screening mammography;
- Group B only: Asymptomatic and recalled for diagnostic testing due to positive findings on recent screening using FFDM, completed within 30 days prior to registration (BI-RADS 0: additional imaging needed);
- Willing to provide a written informed consent.
Exclusion
- Pregnancy or intent to become pregnant;
- Unable or unwilling to tolerate compression associated with mammography;
- Breast implants;
- Breasts too large to allow for adequate positioning for the DBT examination;
- Group B only: Patients with FFDM taken at screening who are unwilling or unable to submit images to ACRIN;
- Group B only: Unwilling to undergo tomosynthesis on both breasts as well as potentially additional diagnostic imaging based on tomosynthesis findings;
- Unable or unwilling to complete screening and (as necessary) diagnostic imaging at same facility;
- Tomosynthesis or mammography within 11 months prior to registration (excluding the screening mammography required for Group B).
Key Trial Info
Start Date :
January 4 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2013
Estimated Enrollment :
558 Patients enrolled
Trial Details
Trial ID
NCT01236781
Start Date
January 4 2011
End Date
December 31 2013
Last Update
March 5 2025
Active Locations (2)
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1
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19118
2
Albery Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141