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

Breast Cancer Screening Clinical Trial

Official title:
A Prospective, Single-Center, Feasibility Study Assessing the Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Identifying Malignant Breast Lesions as an Adjunct to Mammography

Clinical Trial 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.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04102722
Study type Interventional
Source Transonic Imaging, Inc.
Contact Tejas Mehta, MD
Phone 617-667-2506
Email tmehta@bidmc.harvard.edu
Status Recruiting
Phase N/A
Start date January 14, 2020
Completion date November 2021
View Details
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