Non-Inferiority Quantitative Transmission Ultrasound Case Collection Study
Non-Inferiority Quantitative Transmission Ultrasound Case Collection Study
Conduct a case collection study of breast imaging examinations from women with
 mammographically-detected breast lesions for the purpose of conducting subsequent Reader
 Studies.
This is a prospective case collection study for the purpose of collecting cases for the
 subsequent Reader Studies at a minimum of two clinical sites.

 Potential subjects will be recruited from a group of women who have undergone diagnostic
 mammography and demonstrate a mammographic lesion in at least one view. Approximately 300
 women will be enrolled. Subjects will undergo QTUS following a diagnostic XRM with a
 mammographically-detected lesion(s) in at least one mammographic view and will have a lesion
 seen on HHUS corresponding to the XRM lesion(s). Potential Subjects will be eligible for
 enrollment at the time the corresponding lesion is identified on HHUS. All subjects will
 undergo an ultrasound guided aspiration/biopsy with cytology to determine whether the lesion
 is a cyst or solid.

 Each study site is projected to collect approximately 75 cyst cases and 75 solid cases for a
 total of 150 cases, stratified across the four (4) recognized breast tissue density
 categories with at least 50% of cases from subjects with heterogeneous and extremely dense
 breast compositions. The composition of the cyst cases at each site is projected to consist
 of 25 simple cysts and 50 complicated and complex cysts for a total of 75 cyst cases. All
 enrolled subjects will undergo ultrasound guided aspiration or biopsy or surgical excision,
 as applicable for the index lesion. Cytologic or histologic results for all lesions will be
 performed and collected.
Inclusion Criteria:

 -  Female

 -  Age 25 or older

 -  A bra cup size of A through DDD

 -  Willing and able to provide written, signed Informed Consent Form (ICF) after the
 nature of the study has been explained, all questions have been answered, and prior to
 any research-related procedure(s)

 -  Willing and able to comply with all study procedure(s), including possible aspiration
 for a simple cyst

 -  Complete digital mammography views Craniocaudal and Medio-lateral Oblique (CC and MLO)
 for one or both breasts

 -  Mammographically-detected lesion(s) seen on at least one mammographic view and a
 corresponding HHUS correlate(s)

 Exclusion Criteria:

 -  Does not meet all Inclusion Criteria

 -  Currently breastfeeding

 -  History of breast cancer in the past 12 months, except for Fine Needle Aspirations
 (FNA) or Cyst Aspiration

 -  History of breast surgeries or interventional breast procedures in the past 12 months

 -  Normal mammogram at the time of this evaluation

 -  Physical inability to tolerate the procedure on the scanner, i.e. inability to lie
 prone and still for up to 30 minutes at a time

 -  Open wounds, sores or skin rash present on the breast(s) or nipple discharge from the
 scanned breast

 -  Breasts too large for scanner, i.e. bra size larger than DDD or inability to
 successfully "fit" breast after the subject is placed on scanner

 -  Body weight greater than 400 lbs. (180 kg)

 -  Has a concurrent disease or condition which in the judgment of the principal
 investigator disqualifies the subject, from participating in the study