- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04102722
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
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
- Name: Tejas Mehta, MD
- Phone Number: 617-667-2506
- Email: tmehta@bidmc.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Beth Israel Deaconess Medical Center BreastCare Center
-
Contact:
- Tejas Mehta, MD, MPH
- Email: tmehta@bidmc.harvard.edu
-
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:
- 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.
Exclusion Criteria:
- 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
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
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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