Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Ultrasound Imaging With Investigational AI Software | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Single Observational Cohort
- description
- Adult female patients undergoing routine breast ultrasound imaging in a clinical care setting who have a previously placed standard-of-care breast biopsy marker.
- interventionNames
- Device: Breast Ultrasound Imaging With Investigational AI Software
Primary outcomes (1)
- measure
- Successful Identification of Breast Biopsy Marker
- timeFrame
- During the ultrasound imaging examination (single imaging session; approximately 5-10 minutes)
- description
- Whether the investigational software identifies the location of a previously placed standard-of-care breast biopsy marker during ultrasound imaging.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available