Status:
UNKNOWN
Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening
Lead Sponsor:
Transonic Imaging, Inc.
Conditions:
Breast Cancer Screening
Eligibility:
FEMALE
40-74 years
Phase:
NA
Brief Summary
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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
1333 Patients enrolled
Trial Details
Trial ID
NCT04102722
Start Date
January 14 2020
End Date
November 1 2021
Last Update
January 18 2020
Active Locations (1)
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1
Beth Israel Deaconess Medical Center BreastCare Center
Boston, Massachusetts, United States, 02215