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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Cancer Screening

Intervention / Treatment
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* Device: MUST device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: All enrolled subjects will receive breast cancer screening with mammography and MUST
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>All enrolled subjects will undergo breast cancer screening with mammography and the MUST device | Device: MUST device<br>* Imaging with MUST device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with true positive (malignant) breast lesions confirmed by biopsy | Sensitivity of MUST plus mammography versus mammography alone | 14 days | 
| Number of subjects with false positive (benign) breast lesions confirmed by biopsy | Specificity of MUST plus mammography versus mammography alone | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of true positive and false positive breast lesions categorized by BI-RADS breast density category as determined by the screening mammogram | 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 | 14 days | 
| For subjects who undergo biopsy, comparison of MUST results with biopsy results | In the subpopulation of subjects who undergo biopsy, the concordance of MUST with biopsy will be estimated | 60 days | 
| For subjects test positive on mammography (initial BI-RADS score of 0 followed by an additional imaging BI-RADS score of 4 or 5) who undergo biopsy, comparison of MUST and MRI results with biopsy results | 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 | 60 days | 
| Number of subjects with true positive and false positive breast lesions at the 6 month follow up (if applicable) and the 12 month follow up phone call. | 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 | 12 months | 
| Listing of adverse events experienced by subjects | Evaluate the safety of the MUST device by evaluating the adverse event profile | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tomography, ultrasound, mammogram, breast