Case Collection Study in the Evaluation of Doubling Time Rates in Non-Suspicious Breast Masses Using QT Ultrasound Technology
Completed
Conditions studied: Breast Fibroadenoma
In brief
This is a prospective case collection study to collect cases for subsequent statistical studies and future reader studies.
Key facts
- Study ID
- NCT03470051
- Run by
- QT Ultrasound LLC
- People needed
- 27
- Starts
- 2018-02-26
- Expected to finish
- 2020-02-11
- Last updated by the study team
- 2021-03-18
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
- 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)
- Concurrent disease or condition which in the judgment of the Principal Investigator disqualifies the subject from participating in the study
Where it is running
- Memorial Care Long Beach — Long Beach, California, United States
- Marin Breast Health Trial Center — Novato, California, United States
Full record on ClinicalTrials.gov
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