Clinical trial NCT04102722: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Screening
Keywords: tomography
ultrasound
mammogram
breast
Lead sponsor: Transonic Imaging, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-25
Enrollment: 1333
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All enrolled subjects will receive breast cancer screening with mammography and MUST
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects with true positive (malignant) breast lesions confirmed by biopsy
timeFrame: 14 days
measure: Number of subjects with false positive (benign) breast lesions confirmed by biopsy
timeFrame: 14 days
Secondary outcomes:
measure: Number of true positive and false positive breast lesions categorized by BI-RADS breast density category as determined by the screening mammogram
timeFrame: 14 days
measure: For subjects who undergo biopsy, comparison of MUST results with biopsy results
timeFrame: 60 days
measure: 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
timeFrame: 60 days
measure: 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.
timeFrame: 12 months
measure: Listing of adverse events experienced by subjects
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center BreastCare Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Hospital
name: Tejas Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References: