Recruiting

MUST

Sponsor:

Transonic Imaging, Inc.

Code:

NCT04102722

Conditions

Breast Cancer Screening

Eligibility Criteria

Sex: Female

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

MUST device

Study Details

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

Study ID

NCT04102722

Start date

Jan 14, 2020

Status verified date

Jan, 2020

Completion date

Nov, 2021

Anticipated

Primary completion date

Nov, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1333 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Single Arm

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

Interventions

MUST device

Imaging with MUST device

Primary outcome measure

  • Number of subjects with true positive (malignant) breast lesions confirmed by biopsy [ Time Frame: 14 days ]
  • Number of subjects with false positive (benign) breast lesions confirmed by biopsy [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Tejas Mehta, MD

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

Locations

Beth Israel Deaconess Medical Center BreastCare Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Tejas Mehta, MD, MPH

tmehta@bidmc.harvard.edu

Principal Investigator:

Tejas Mehta, MD, MPH

More Information

Sponsor

Transonic Imaging, Inc.

Last update posted

Jan 18, 2020

Last verified

Jan, 2020

Keywords

  • tomography
  • ultrasound
  • mammogram
  • breast

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Transonic Imaging, Inc. on 2020-01-18.