This is a single-center, pilot study being conducted to evaluate the safety and
performance of the investigational device (MUST) in detecting malignant lesions in breast
tissue.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04102722.
This is a single-center, prospective, pilot study in which all enrolled subjects will
receive the same screening mammography procedures (i.e., 3D mammography plus MUST).
Subjects will have between 1 and 4 clinic visits. The number of visits will be based upon
the mammography and MUST findings, and whether additional procedures, such as MRI,
biopsy, or a repeat MUST are warranted.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationTransonic Imaging, Inc.
