Prospective Ultrasound Data Collection Study for AI-Based Detection of Breast Biopsy Markers (NCT07427407) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prospective Ultrasound Data Collection Study for AI-Based Detection of Breast Biopsy Markers
United States100 participantsStarted 2026-05
Plain-language summary
The goal of this observational study is to collect ultrasound imaging data to support the development and refinement of an artificial intelligence (AI)-enhanced ultrasound software designed to detect and localize standard-of-care breast biopsy markers in adult female patients undergoing surgical excision of a breast tumor. The main questions it aims to answer are:
Can the study software identify the location of previously placed breast biopsy markers during routine ultrasound examinations?
Participants will undergo limited breast ultrasound imaging during a standard-of-care scheduled clinical visit. During the ultrasound imaging, the ultrasound system will automatically record the ultrasound images for the development and training of the AI software
The study does not change standard medical care, and no diagnostic or treatment decisions are made based on the study software.
Who can participate
Age range
21 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:
* Participant can understand and sign informed consent documentation
* Participant has a previous placement of one of the standard-of-care breast biopsy markers
Exclusion Criteria:
* Previous breast cancer surgery in the region of interest
* Life expectancy \<6 months
* Allergy and/or hypersensitivity to titanium and/or nickel and/or ultrasound gel
* Carcinoma unknown primary
* Patient does not accept ultrasound examinations
* Patient with skin disease of areas to be examined (breast and/or axillary)
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.
What they're measuring
1
Successful Identification of Breast Biopsy Marker
Timeframe: During the ultrasound imaging examination (single imaging session; approximately 5-10 minutes)