Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening
- Female subject scheduled for routine screening mammogram
- Not currently pregnant or breastfeeding
- Age 40 to 74 years, inclusive
- Weight less than 115 kg
- Able to provide written informed consent
- Willing to comply with study protocol and follow-up recommendations.
- Breast implants
- Signs or symptoms of breast disease including changes in the size or shape of breast tissue, palpable lump, bloody or spontaneous clear nipple discharge, and/or eczema of the nipple
- Weeping rash, open wounds, or unhealed sores on the breast
- Bilateral mastectomy or unilateral mastectomy
- Unable to lay prone on the scan table for up to 16 minutes
- Unable to have breast positioned into the MUST device
- Any breast surgeries in the past 12 months
- History of cancer diagnosis and/or treatment in the past 5 years.
- Unable or unwilling to undergo MRI if indicated
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 Phase Phase NA
Trial Type Screening
Transonic Imaging, Inc.
- Primary ID MUST-02-001
- Secondary IDs NCI-2020-01960
- Clinicaltrials.gov ID NCT04102722