Sterling

Researchers are evaluating a new mammography device to determine its safety, effectiveness, and usefulness in breast cancer screening and diagnosis. The study aims to support further technology development of this investigational mammography technology by collecting real-world clinical data. Women who need a screening or diagnostic mammogram or breast biopsy will have an exam using the new investigational mammography device. This device will be tested to see if it can safely acquire mammograms and provide images of clinically acceptable quality over a period of four years. Participants will undergo mammograms with the investigational device, and researchers will assess the image quality and safety of the device throughout the study. The evaluation period lasts up to four years, during which the device's clinical utility in breast imaging will be closely monitored.

Researchers are evaluating a new contrast-enhanced mammography (CEM) software application used with a new mammography device to help detect breast abnormalities and support continuing software development. This prospective, multi-center study focuses on women aged 35 and older who have suspicious findings or breast abnormalities on screening or diagnostic mammograms and are scheduled for diagnostic exams or biopsy procedures. The study aims to verify and validate image quality assessments to support the clinical efficacy of the CEM software. All participants will undergo a contrast-enhanced mammography exam using the investigational device. This technique supplements standard 2D digital mammography with intravenous iodinated contrast to highlight areas of increased blood flow, aiding in cancer detection and lesion characterization. The CEM software works as an adjunct following mammography and ultrasound exams to localize and evaluate known or suspected lesions. The study collects de-identified contrast-enhanced breast images to support ongoing software technology development. Participants will be involved in the imaging exam and monitored for outcomes including the number of subjects with lesions over 18 months. Researchers will assess image quality and safety while collecting data from diagnostic and biopsy procedures. The study includes screening, diagnostic imaging, and follow-up to gather necessary clinical information, with no upper age limit specified. Safety monitoring considers possible allergic reactions and renal function risks related to the contrast agent.