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

Protocol Documents

Protocol-ACRIN PA 4006, Amendment 1, 8.4.11 [PDF]

SOC-ACRIN PA 4006, Amendment 1, 8.4.11 [PDF]

Informed Consent-ACRIN PA 4006 [DOC]

Principal Investigator:  Emily F. Conant, MD

Status:  Accrual Completed

Main Objective: The objective of this study is to evaluate the specificity
of 2-D full-filed digital mammography versus a combination of 2-D and
3-D tomosynthesis imaging in breast cancer screening. This study will
measure specificity by participant call-back rate per 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. Prospective and retrospective
imaging data will be assessed.

Participants: Asymptomatic women 25 years and older with no history of breast
cancer will be recruited from a prospective population of patient scheduled for
screening mammography (Group A). A similar population of women called back
from screening for abnormalities detected on 2-D full-field digital mammography
will be recruited to provide an enriched population of true-positive and false-
positive digital mammography and tomosythesis cases, where tomosynthesis
is added to the diagnostic work-up for these participants (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 positions of the breast for tomosynthesis are excluded
from trial participation.

Study Design Summary: A total of 550 participants will be recruited for this
trial; 500 will be recruited at time of screening mammography to join Group A
and 50 will be recruited at call-back for abnormalities found during screening
to join the enriched population of Group B. Accrual will be accomplished in
12 months at two institutions in Pennsylvania.