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Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening

Trial Status: Active

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.

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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


Beth Israel Deaconess Medical Center
Status: ACTIVE
Contact: Tejas Shirish Mehta
Phone: 617-667-2506

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

Lead Organization
Transonic Imaging, Inc.

  • Primary ID MUST-02-001
  • Secondary IDs NCI-2020-01960
  • ID NCT04102722