Non-Inferiority Quantitative Transmission Ultrasound Case Collection Study

A Prospective Multi-center Case Collection Study of Breast Imaging Examinations From Women With Mammographically-detected Lesion(s) to Evaluate the Non-inferiority of Digital Mammography (XRM) and Quantitative Transmission Ultrasound (QTUS) Together Compared to XRM and Hand Held Ultrasound (HHUS) Together in the Evaluation of Lesion(s) Detected With Diagnostic Mammography.

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