Status:
COMPLETED
Case Collection Study in the Evaluation of Doubling Time Rates in Non-Suspicious Breast Masses Using QT Ultrasound Technology
Lead Sponsor:
QT Ultrasound LLC
Conditions:
Breast Fibroadenoma
Eligibility:
FEMALE
18+ years
Brief Summary
This is a prospective case collection study to collect cases for subsequent statistical studies and future reader studies.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 26 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 11 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03470051
Start Date
February 26 2018
End Date
February 11 2020
Last Update
March 18 2021
Active Locations (2)
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1
Memorial Care Long Beach
Long Beach, California, United States, 90806
2
Marin Breast Health Trial Center
Novato, California, United States, 94949