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Comparison of Full-Field Digital Mammography With Digital Breast Tomosynthesis Image Acquisition in Relation to Screening Call-Back Rate

Phase 2/Phase 3
25 Years
Open (Enrolling)
Breast Neoplasms

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Trial Information

Comparison of Full-Field Digital Mammography With Digital Breast Tomosynthesis Image Acquisition in Relation to Screening Call-Back Rate

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 of women called back from screening for 2-D FFDM-detected abnormalities
will also be recruited to provide an enriched population of true-positive and false-positive
2-D FFDM and tomosynthesis cases (Group B). Pregnant women, women unable to tolerate
compression of the breast associated with mammography, women with implants, and women with
breasts too large to accommodate adequate positioning of the breast for DBT are excluded
from trial participation.

A total of 550 participants will be recruited--500 women will enroll for collection of
prospective imaging data in this trial (Group A); 50 additional participants, recalled for
diagnostic assessment after positive screening findings, will be recruited for DBT imaging
data collection and retrospective image analysis (Group B). Participating institutions for
this trial will be clinical research institutions in Pennsylvania with Hologic tomosynthesis

Inclusion Criteria:

- 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 Criteria:

- 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).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Primary Aim: Recall Rates

Outcome Description:

To compare recall rates of FFDM to the limited DBT set (digital breast two-view tomosynthesis with low-dose MLO) [Group A].

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Emily F. Conant, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hospital of University of Pennsylvania


United States: Institutional Review Board

Study ID:




Start Date:

December 2010

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • breast cancer
  • screening
  • diagnostics
  • diagnosis
  • high-risk
  • breast neoplasms
  • digital mammography
  • mammography
  • tomosynthesis
  • dense breasts
  • radiation dose
  • comparison
  • Hologic
  • Pennsylvania
  • Philadelphia
  • breast study
  • mammo
  • tomo
  • mammary
  • Breast Neoplasms
  • Neoplasms



Hospital of University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Albery Einstein Medical CenterPhiladelphia, Pennsylvania  19141