Patient-Assisted Compression in 3D - Impact on Image Quality and Workflow

The study population will consist of adult asymptomatic women presenting for screening 2D mammography. One breast of each subject will be identified as the "breast of interest," which will undergo study-specific 3D imaging consisting of two-view (craniocaudal and mediolateral oblique) PA compression and image acquisition, followed by two-view technologist-controlled (TC) compression and image acquisition. The breast of interest will be randomly assigned to either the first breast imaged during the exam or the second breast imaged. TC compression and imaging, and procedures performed on the subject's other breast will be conducted per standard of care.

Following image acquisition, 3D image quality evaluation will be conducted by Mammography Quality Standards Act-qualified readers. Prior to the reading session, images will be de-identified and the following information will be removed from the DICOM header to blind readers to the compression mode used during acquisition: time stamp, compression force, and breast thickness. The image sets will also be randomized for presentation during the image attribute reviews. Two (2) readers will evaluate each PAC and TC compression image set collected from each subject's breast of interest and assess the acceptability of image attributes, as defined in the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full-Field Digital Mammography System (2012). A third reader will provide adjudication, if there is disagreement for a given image set's overall clinical image quality.

Workflow data, including the incidence of technologist intervention during acquisition and need for repeat image acquisition, will also be collected.

The proportion of PAC image sets that are of equal or higher acceptability than TC image sets will be calculated. A 95% confidence interval will be calculated using asymptotic method with continuity correction. The proportion of image sets indicated for repeated image acquisition when using PA mode or TC mode will be summarized. Other endpoint data will be summarized using descriptive statistics. No statistical hypothesis is being tested in this study.

Inclusion criteria

• Are women aged 40 years or older;
• Are asymptomatic and scheduled for screening mammography;
• Have left and right breasts;
• Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;
• Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;
• Are able and willing to comply with study procedures; and
• Are able and willing to provide written informed consent to participate.

Exclusion criteria

• Are women aged 40 years or older;
• Are asymptomatic and scheduled for screening mammography;
• Have left and right breasts;
• Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;
• Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;
• Are able and willing to comply with study procedures; and
• Are able and willing to provide written informed consent to participate.