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

Transonic Imaging, Inc.1,333 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

1,333

Conditions

Breast Cancer Screening

Interventions

MUST deviceDEVICE

Imaging with MUST device

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 74 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female subject scheduled for routine screening mammogram 2. Not currently pregnant or breastfeeding 3. Age 40 to 74 years, inclusive 4. Weight less than 115 kg 5. Able to provide written informed consent 6. Willing to comply with study protocol and follow-up recommendations. Exclusion Criteria: 1. Breast implants 2. 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 3. Weeping rash, open wounds, or unhealed sores on the breast 4. Bilateral mastectomy or unilateral mastectomy 5. Unable to lay prone on the scan table for up to 16 minutes 6. Unable to have breast positioned into the MUST device 7. Any breast surgeries in the past 12 months 8. History of cancer diagnosis and/or treatment in the past 5 years. 9. Unable or unwilling to undergo MRI if indicated

Locations (1)

Beth Israel Deaconess Medical Center BreastCare Center

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Number of subjects with true positive (malignant) breast lesions confirmed by biopsy

Sensitivity of MUST plus mammography versus mammography alone

Time frame: 14 days

Number of subjects with false positive (benign) breast lesions confirmed by biopsy

Specificity of MUST plus mammography versus mammography alone

Time frame: 14 days

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Central Contacts

Tejas Mehta, MD

CONTACT

617-667-2506 tmehta@bidmc.harvard.edu

Data from ClinicalTrials.gov

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