Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All enrolled subjects will undergo breast cancer screening with mammography and the MUST device

MUST device

Tejas Mehta, MD

Tejas Mehta, MD, MPH

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.

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.

All enrolled subjects will receive breast cancer screening with mammography and MUST

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

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

Sensitivity of MUST plus mammography versus mammography alone

Specificity of MUST plus mammography versus mammography alone

Assess the sensitivity and specificity by BI-RADS breast density category as determined by the Visit 1 mammogram, for MUST plus mammography vs mammography alone

In the subpopulation of subjects who undergo biopsy, the concordance of MUST with biopsy will be estimated

In the subpopulation of subjects who test positive on mammography (BI-RADS score of 4 or 5) and have a biopsy, sensitivity and specificity will be assessed and compared between MUST and MRI and biopsy results

The co-primary endpoint of overall sensitivity and specificity will be reassessed after subjects have had the opportunity to complete the Month 6 MUST re-evaluation visit, if applicable, and again when all subjects have had the opportunity to complete the Month 12 follow-up phone call to identify events of interval cancer for MUST plus mammography as well as MUST alone

Evaluate the safety of the MUST device by evaluating the adverse event profile

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening	NCT04102722	Breast Cancer S...	MUST device	40 Years - 74 Years	Transonic Imaging, Inc.
Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening	NCT04102722	Breast Cancer S...	MUST device	40 Years - 74 Years	Transonic Imaging, Inc.
Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening	NCT04102722	Breast Cancer S...	MUST device	40 Years - 74 Years	Transonic Imaging, Inc.

Spots Global Cancer Trial Database for must device

Every month we try and update this database with for must device cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for must device

Every month we try and update this database with for must device cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for must device cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.