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

Status unconfirmed · Not applicable

Conditions studied: Breast Cancer Screening

In brief

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.

Key facts

Study ID

NCT04102722

Run by

Transonic Imaging, Inc.

People needed

1333

Starts

2020-01-14

Expected to finish

2021-11-01

Last updated by the study team

2020-01-18

Who can join

Age: 40 and older, up to 74. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Beth Israel Deaconess Medical Center BreastCare Center — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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