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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1333 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-14

Study Completion Date

2021-11-30

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.

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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.

Conditions

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Breast Cancer Screening

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Single Arm

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

Group Type EXPERIMENTAL

MUST device

Intervention Type DEVICE

Imaging with MUST device

Interventions

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MUST device

Imaging with MUST device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes