Study of 3D Multimodal Ultrasound Imaging for Diagnosing Breast Tumors in Adult Women

What this Trial Is About

Researchers are evaluating a new ultrasound imaging method to diagnose breast masses in adult women. This study aims to assess the effectiveness of 3D multimodal ultrasound imaging in detecting breast tumors and improving diagnostic accuracy, led by the Mayo Clinic. The trial focuses on women who have solid breast lesions and are scheduled for biopsy as part of their clinical care. Participants will undergo 3D multimodal ultrasound imaging using two types of diagnostic ultrasound scanners the GE Logiq E10 clinical ultrasound scanner, which captures 2D B-mode, Doppler, and shear wave elastography images, and the Verasonics research scanner, which provides 3D B-mode imaging, microvessel imaging, and shear wave elastography. This imaging is performed before the participants have a clinically indicated breast tumor biopsy. During the study, researchers will collect imaging data and assign a Breast Imaging Reporting and Data System BI-RADS score at baseline as the primary outcome measure. Participants are women aged 18 years or older with solid breast lesions of 3 mm or larger. Safety monitoring and follow-up details are not specified, but participation involves undergoing the ultrasound imaging and biopsy procedures as part of standard clinical care. The trial is expected to conclude by the end of 2026.

3D Ultrasound Breast Imaging