Digital Versus Film-Screen Mammography

Protocol Documents

Protocol-ACRIN 6652 Amendment 9, 10.27.03 [PDF]

SOC-ACRIN 6652 Amendment 9, 10.27.03 [PDF]

Principal Investigator: Etta Pisano, MD

Status: Primary-Aim Paper Published/Other Publications in Process

Main Objective: To compare the diagnostic performance of digital mammography and screen-film mammography, as measured by the area under the ROC curve, sensitivity, specificity, and positive and negative predictive values in a prospectively enrolled screening cohort of asymptomatic women, across all digital mammography machine types.

Study Design Summary: All women will undergo both digital and screen-film mammography. Each examination will be interpreted independently and work-up will proceed based on the findings of either study. Truth regarding breast cancer status for all participants will be determined either through the results of breast biopsy, if that occurs, or as a result of one year of follow-up without clinical evidence of disease. An expert breast pathologist will reread all pathologic specimens.

Participants: Asymptomatic women presenting for screening mammography will be enrolled into this trial at 34 centers in the U.S. and Canada.