Prospective Ultrasound Data Collection Study for AI-Based Detection of Breast Biopsy Markers
A Prospective, Non-Interventional, Observational Study to Collect Ultrasound Imaging Data for the Development of an AI-Based Software for the Detection and Visualization of Breast Biopsy Markers
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 21 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Ultrasound, Biopsies, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "Participants will undergo limited breast ultrasound imaging during a standard-of-care scheduled clinical visit."
- "Study Design and Setting This is a prospective, non-interventional observational study designed to collect ultrasound imaging data and related metadata to support the development, refinement, and performance characterization of an artificial intelligence (AI)-enhanced ultrasound software intended to detect and localize standard-of-care breast biopsy markers."
- "All ultrasound examinations are performed as part of routine clinical care for patients undergoing evaluation and planned surgical excision of a breast tumor."
- "Study Procedures During a scheduled clinical visit, participants undergo limited B-mode breast ultrasound imaging using an FDA-cleared ultrasound system provided for the study."
- "Ultrasound image data are automatically recorded by the system during the examination."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study collects breast ultrasound images to help develop AI software that finds markers placed during a breast biopsy, a test that removes tissue. It is for adult women with these markers who are having surgery to remove a breast tumor. Images are recorded during a regular care visit, and the software does not guide care or treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Can understand and sign a form agreeing to join the study.
- Has a standard breast biopsy marker already in place.
Who can't join
- Had breast cancer surgery in the area being studied.
- Is expected to live less than 6 months.
- Has an allergy or sensitivity to titanium, nickel, or ultrasound gel.
- Has cancer whose starting location is unknown.
- Does not agree to ultrasound exams.
- Has a skin disease in the breast or armpit area to be examined.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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)
Study sites (1)
NY
- Columbia University Irving Medical Center · New York, NY 10032Katja Pinker-Domenig, MD, PhD · Principal investigatorMore trials in New York