Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates

Status:	Archived
Conditions:	Breast Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	December 2010

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

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 breast cancer screening. Specificity, in this study, will be
measured by the participant call-back rate by each modality. Varying combinations of 2-D
mammography and tomosynthesis projections will be evaluated to optimize the screening
paradigm and limit radiation exposure when tomosynthesis is incorporated. Both prospective
and retrospective imaging data will be assessed.

Hypothesis: Digital breast tomography (DBT) will improve the specificity of breast cancer
screening as measured by a reduction in the call-back rate while maintaining the sensitivity
of cancer detection. This improved accuracy will be achieved by the optimization of the
imaging sequence and number of views obtained at a capped radiation dose in the combined DBT
and 2-D screening sequence.

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
units.

We found this trial at

sites

Hospital of the University of Pennsylvania

3400 Spruce St
Philadelphia, Pennsylvania 19104

(215) 662-4000