Evaluation of the Bexa™ Breast Examination (BBE)

Objective The "Bexa Breast Exam," or "BBE," for the purposes of this study is defined as the use of a Bexa device in conjunction with a portable, focused ultrasound examination ("spot ultrasound") to identify and further evaluate abnormal breast masses including cancer. Commercially, this combination of Bexa plus focused ultrasound is called "Bexa Plus." This study compares the use of the Bexa Breast Exam (BBE/Bexa Plus) as a breast cancer early detection examination with the current standard of care digital breast tomosynthesis. The specific objectives are: 1. To measure the sensitivity and specificity of BBE as compared to digital breast tomosynthesis. 2. Measure the proportion of women receiving a Bexa Breast Exam that require additional imaging studies. Hypothesis The purpose of this study is to demonstrate that Bexa Breast Examination's sensitivity and specificity in identifying abnormal breast masses are equal to or superior than the standard accepted mammography with tomosynthesis.

Sex

Female

Minimum age

30 Years

Maximum age

80 Years

Inclusion Criteria:

1. Individuals who are scheduled for a diagnostic or screening mammogram.
2. Patients of all races, ethnicities, and socio-economic background
3. Signed informed consent obtained prior to any study assessments and procedures.
4. Age 30-80 years of age and female.

Exclusion Criteria:

* Positive findings with a size in their greatest dimension \> 2cm as measured by ultrasound. These masses are frequently palpable if not overtly visible and our focus, and that of other modalities used in early detection, is primarily but not exclusively the identification of non-palpable masses.
* Positive findings that cause a visible and obvious deformity of the breast or alteration in the skin appearance of the breast.
* Women with breast tenderness significant enough to prevent completion of any of the study examinations. Both ultrasound and Bexa require a light degree of pressure on the breast; certain women, very few, have enough breast tenderness that they cannot tolerate the pressure of either Bexa or ultrasound.
* Women with breast surface scarring significant enough to prevent effective BBE (keloid scarring from a previous procedure on the breast, for example).
* Greater than 3 positive findings in a given breast.
* Women who are unable to comprehend or unwilling to sign an informed consent form.
* Women ages \< 30 and \> 80 years of age.
* Pregnant women.
* Women who have had mastectomy - unilateral or bilateral.
* Women who have had breast cancer within the last 2 years

• BACKGROUNDKaufman CS, et al., Objective measurement of the physical exam using a new device: reproducible triage of palpable masses. Breast Cancer Research and Treatment, 2004; 88; supp 1:S223-4- SABCS 2004.
• RESULTMiglioretti DL, Lange J, van den Broek JJ, Lee CI, van Ravesteyn NT, Ritley D, Kerlikowske K, Fenton JJ, Melnikow J, de Koning HJ, Hubbard RA. Radiation-Induced Breast Cancer Incidence and Mortality From Digital Mammography Screening: A Modeling Study. Ann Intern Med. 2016 Feb 16;164(4):205-14. doi: 10.7326/M15-1241. Epub 2016 Jan 12. PMID 26756460
• RESULTNational Center for Health Statistics (US). Health, United States, 2016: With Chartbook on Long-term Trends in Health. Hyattsville (MD): National Center for Health Statistics (US); 2017 May. Report No.: 2017-1232. Available from http://www.ncbi.nlm.nih.gov/books/NBK453378/ PMID 28910066
• RESULTSarvazyan A, Egorov V, Son JS, Kaufman CS. Cost-effective screening for breast cancer worldwide: current state and future directions. Breast Cancer (Auckl). 2008;1:91-9. doi: 10.4137/bcbcr.s774. Epub 2008 Jul 2. PMID 19578481