Case Collection Study in the Evaluation of Doubling Time Rates in Non-Suspicious Breast Masses Using QT Ultrasound Technology

Inclusion Criteria:

1. Female

2. Age 18 or older

3. Willing to receive QT Ultrasound Breast Scans

4. Willing to undergo an ultrasound-guided needle breast biopsy if performed after
enrollment in the study

5. Willing and able to provide Informed Consent prior to any research-related
procedure(s)

6. Have an identified solid non-suspicious breast mass

Exclusion Criteria:

1. Pregnancy

2. Currently breastfeeding

3. Magnetic material in the chest which in the judgement of the Principal Investigator
would interfere or be impacted by the magnets utilized with the study device.

4. Not willing to provide information for primary care physician

5. History of breast cancer

6. History of treated or untreated cancer of a non-breast origin which in the judgment of
the Principal Investigator would be a concern for metastatic disease to the breast

7. Physical inability to tolerate the QT scan, i.e. inability to lie prone and still for
up to 30 minutes at a time

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

9. 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

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

11. Concurrent disease or condition which in the judgment of the Principal Investigator
disqualifies the subject from participating in the study