CompletedNot Applicable

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

United States27 participantsStarted 2018-02-26

Plain-language summary

This is a prospective case collection study to collect cases for subsequent statistical studies and future reader studies.

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Female
✓. Age 18 or older
✓. Willing to receive QT Ultrasound Breast Scans
✓. Willing to undergo an ultrasound-guided needle breast biopsy if performed after enrollment in the study
✓. Willing and able to provide Informed Consent prior to any research-related procedure(s)
✓. Have an identified solid non-suspicious breast mass

✕. Pregnancy
✕. Currently breastfeeding
✕. 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.
✕. Not willing to provide information for primary care physician
✕. History of breast cancer
✕. 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
✕. Physical inability to tolerate the QT scan, 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(s)

Breast mass doubling time change

Timeframe: 90 days

NCT IDNCT03470051

SponsorQT Ultrasound LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-02-11