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

January 14, 2020 updated by: Transonic Imaging, Inc.

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

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.

Study Overview

Status

Unknown

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1333

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center BreastCare Center
        • Contact:
        • Principal Investigator:
          • Tejas Mehta, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
All enrolled subjects will undergo breast cancer screening with mammography and the MUST device
Imaging with MUST device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with true positive (malignant) breast lesions confirmed by biopsy
Time Frame: 14 days
Sensitivity of MUST plus mammography versus mammography alone
14 days
Number of subjects with false positive (benign) breast lesions confirmed by biopsy
Time Frame: 14 days
Specificity of MUST plus mammography versus mammography alone
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of true positive and false positive breast lesions categorized by BI-RADS breast density category as determined by the screening mammogram
Time Frame: 14 days
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
14 days
For subjects who undergo biopsy, comparison of MUST results with biopsy results
Time Frame: 60 days
In the subpopulation of subjects who undergo biopsy, the concordance of MUST with biopsy will be estimated
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
Time Frame: 60 days
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
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.
Time Frame: 12 months
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
12 months
Listing of adverse events experienced by subjects
Time Frame: 6 months
Evaluate the safety of the MUST device by evaluating the adverse event profile
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tejas Mehta, MD, Beth Israel Deaconess Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2020

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

June 11, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • MUST-02-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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