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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Successful Identification of Breast Biopsy Marker
研究概览
简要总结
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.
详细描述
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 participation does not alter standard imaging protocols, clinical workflow, or treatment decisions.
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. The system includes investigational software that displays marker localization output during image acquisition. The software output is not used to guide or alter clinical decision-making.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant can understand and sign informed consent documentation
- •Participant has a previous placement of one of the standard-of-care breast biopsy markers
排除标准
- •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)
研究组 & 干预措施
Single Observational Cohort
Adult female patients undergoing routine breast ultrasound imaging in a clinical care setting who have a previously placed standard-of-care breast biopsy marker.
干预措施: Breast Ultrasound Imaging With Investigational AI Software (Device)
结局指标
主要结局
Successful Identification of Breast Biopsy Marker
时间窗: During the ultrasound imaging examination (single imaging session; approximately 5-10 minutes)
Whether the investigational software identifies the location of a previously placed standard-of-care breast biopsy marker during ultrasound imaging.
次要结局
未报告次要终点