Spots Global Cancer Trial Database for Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening

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Trial Identification

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

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

Study ID: NCT04102722

Conditions

Breast Cancer Screening

Interventions

MUST device

Study Description

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 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.