Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fujifilm Medical Systems USA, Inc.
The safety and effectiveness of FFDM + DBT are both linked to the ability of radiologists interpreting FFDM + DBT images to accurately diagnose breast cancer. Each study endpoint therefore addresses both safety and effectiveness.
Age
18–any
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
Eligible subjects under protocol FMSU2013-004A, defined as female subjects with known true clinical status and with complete FFDM and DBT examinations, in which there is sufficient anatomical coverage, sufficient contrast, and no significant motion or other artifacts, as determined by the image-acquisition sites.
You may not be if
Subjects who are in violation of protocol FMSU2013-004A.
Subjects with unknown clinical status.
Any subject whose positive mammogram was not read during the truthing process (see section 8) will not be considered for the pivotal MRMC reader study.
