Trial Information

Digital VS. Screen-Film Mammography

OBJECTIVES:

- Compare the diagnostic performance of digital mammography vs screen-film mammography,
as measured by the area under the Receiver Operating Characteristic (ROC) curve,
sensitivity, specificity, and positive and negative predictive values, in the detection
of breast cancer in women.

- Compare the diagnostic accuracy of the digital mammogram obtained using each of the
individual manufacturer's digital units vs screen-film mammography through
retrospective reader studies.

- Determine the effects of patient characteristics, including age, lesion type,
pathologic diagnosis, menopausal and hormonal status, breast density, and family
history, on diagnostic accuracy of digital mammography.

- Determine the effects of technical parameters, including display type, machine type,
and detector spatial and contrast resolution, on diagnostic accuracy of digital
mammography.

- Determine the effect of reduced false-positive mammograms that are expected with
digital mammography on the health-related quality of life and personal anxiety of women
undergoing this screening experience.

- Compare the diagnostic performance of digital mammography with the rate of cancer in a
set of cases through a retrospective reader study.

- Compare the effect of softcopy vs printed film display on the diagnostic performance of
digital mammography through a retrospective reader study.

- Compare the effect of breast density on the diagnostic accuracy of digital mammography
vs screen-film mammography through a retrospective reader study.

- Compare the image quality and breast radiation dose in digital vs screen-film
mammography in these participants.

- Determine the temporal variations in image quality, breast radiation dose, and other
quality control parameters in the participating study centers.

OUTLINE: This is a randomized, multicenter study. Participants with postitive screening
results are stratified according to age (under 50 vs 50-59 vs 60-70 vs over 70).
Participants are randomized to one of two treatment arms.

- Arm I: Participants undergo a two-view screen-film mammogram followed by a two-view
digital mammogram of each breast.

- Arm II: Participants undergo a two-view digital mammogram followed by a two-view
screen-film mammogram of each breast.

Quality of life is assessed before the screening mammogram in the first 800 women enrolled.
In an additional 1,200 participants (600 with positive screening results and 600 with
negative screening results), quality of life is assessed shortly after the screening
mammogram and at 1 year.

Participants are followed at 1 year with a repeat screen-film or digital mammogram.

PROJECTED ACCRUAL: A total of 49,500 participants (24,750 per arm) will be accrued for this
study within 18 months.