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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102722
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Transonic Imaging, Inc.

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Screening Device: MUST device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1333 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All enrolled subjects will receive breast cancer screening with mammography and MUST
Masking: None (Open Label)
Primary Purpose: 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
Actual Study Start Date : January 14, 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of subjects with true positive (malignant) breast lesions confirmed by biopsy [ Time Frame: 14 days ]
    Sensitivity of MUST plus mammography versus mammography alone

  2. Number of subjects with false positive (benign) breast lesions confirmed by biopsy [ Time Frame: 14 days ]
    Specificity of MUST plus mammography versus mammography alone


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Listing of adverse events experienced by subjects [ Time Frame: 6 months ]
    Evaluate the safety of the MUST device by evaluating the adverse event profile



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04102722


Contacts
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Contact: Tejas Mehta, MD 617-667-2506 tmehta@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center BreastCare Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Tejas Mehta, MD, MPH       tmehta@bidmc.harvard.edu   
Principal Investigator: Tejas Mehta, MD, MPH         
Sponsors and Collaborators
Transonic Imaging, Inc.
Investigators
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Principal Investigator: Tejas Mehta, MD Beth Israel Deaconess Hospital
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Responsible Party: Transonic Imaging, Inc.
ClinicalTrials.gov Identifier: NCT04102722    
Other Study ID Numbers: MUST-02-001
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Transonic Imaging, Inc.:
tomography
ultrasound
mammogram
breast
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases