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

NCT04102722 | Unknown FDA Device

• 1 other identifier: MUST-02-001
• Study Type: interventional
• Target: 1,333
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Screening

Keywords

tomography; ultrasound; mammogram; breast

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Number of true positive and false positive breast lesions categorized by BI-RADS breast density category as determined by the screening mammogram

  14 days

• For subjects who undergo biopsy, comparison of MUST results with biopsy results

  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

  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.

  12 months

• Listing of adverse events experienced by subjects

  6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Device: MUST device

Interventions

MUST device DEVICE

Imaging with MUST device

Single Arm

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Transonic Imaging, Inc.: lead

Study Sites (1)

Beth Israel Deaconess Medical Center BreastCare Center

Boston, Massachusetts, 02215, United States

RECRUITING

Study Officials

• Tejas Mehta, MD

  Beth Israel Deaconess Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tejas Mehta, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: September 25, 2019
• Study Start: January 14, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2021
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (1)