Case Collection Study in the Evaluation of Doubling Time Rates in Non-Suspicious Breast Masses Us… (NCT03470051) | Clinical Trial Compass
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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)