Study of the Photo-Acoustic and Ultrasound MammoScope PAM3 to Detect Benign and Malignant Breast Lesions in Women

What this Trial Is About

Researchers are evaluating the Photo-Acoustic Imager 3 PAM3 to detect both benign and malignant breast lesions in women visiting an outpatient clinic. The study also assesses the devices accuracy in locating and sizing breast lesions compared to standard imaging, while considering breast density and BI-RADS score. Additional goals include examining the devices usability, patient satisfaction, safety, and developing a dedicated PAM3 terminology. All participants will undergo imaging using the PAM3 device. During the procedure, patients lie face down with one breast positioned in a water-filled aperture supported by a plastic cup. Infrared light is directed onto the breast, and movements in the water caused by light absorption by red blood cells are captured by ultrasound detectors to create a 3D image. This is a Phase 2 study conducted over about one year. Participants will be monitored for the performance of the PAM3 throughout the study period, including measures like sensitivity, specificity, positive predictive value, and patient satisfaction. Safety and system usability are also tracked. The study involves questionnaires to assess patient experience, and adverse events are recorded. The total involvement lasts approximately one year, with evaluations conducted during and after imaging sessions.

Photo-Acoustic and Ultrasonographic Mammoscope