Breast Cancer ScreeningNCT04102722
Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening
A study testing MUST device in people with Breast Cancer Screening, run by Transonic Imaging, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Screening
- What is being tested?
- MUST device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,333 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2020to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center BreastCare Center
Boston, Massachusetts, 02215
Tejas Mehta, MD, MPH, tmehta@bidmc.harvard.edu
Tejas Mehta, MD, MPH
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer Screening
- Being tested
- MUST device
- Keywords
- tomography, ultrasound, mammogram, breast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUST deviceDevice
Imaging with MUST device
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All enrolled subjects will undergo breast cancer screening with mammography and the MUST device Receives: Device: MUST device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with true positive (malignant) breast lesions confirmed by biopsy
Sensitivity of MUST plus mammography versus mammography alone
Measured: 14 days
Number of subjects with false positive (benign) breast lesions confirmed by biopsy
Specificity of MUST plus mammography versus mammography alone
Measured: 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
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
Measured: 14 days
For subjects who undergo biopsy, comparison of MUST results with biopsy results
In the subpopulation of subjects who undergo biopsy, the concordance of MUST with biopsy will be estimated
Measured: 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
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
Measured: 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.
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
Measured: 12 months
Listing of adverse events experienced by subjects
Evaluate the safety of the MUST device by evaluating the adverse event profile
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start14 Jan 2020
- Primary completionNov 2020 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled subjects will receive breast cancer screening with mammography and MUST
- Masking
- None (open label)
- Enrolment
- 1,333 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transonic Imaging, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tejas Mehta, MD, Principal investigator, Beth Israel Deaconess Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102722
- Sponsor's protocol ID
- MUST-02-001
- Status last verified
- Jan 2020
- First submitted
- 11 Jun 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04102722
- Acronym / sponsor ID
- MUST-02-001
- Conditions
- Breast Cancer Screening
- Keywords
- tomography, ultrasound, mammogram, breast
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,333 participants (estimated)
- Lead sponsor
- Transonic Imaging, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled subjects will receive breast cancer screening with mammography and MUST
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: MUST deviceAll enrolled subjects will undergo breast cancer screening with mammography and the MUST device |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MUST deviceImaging with MUST device | Device | Single Arm |
Primary outcome
Number of subjects with true positive (malignant) breast lesions confirmed by biopsy
Time frame: 14 days
Sensitivity of MUST plus mammography versus mammography alone
Number of subjects with false positive (benign) breast lesions confirmed by biopsy
Time frame: 14 days
Specificity of MUST plus mammography versus mammography alone
5 secondary outcomes
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
For subjects who undergo biopsy, comparison of MUST results with biopsy results
Time frame: 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
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
Listing of adverse events experienced by subjects
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tejas Mehta, MD principal investigator
Beth Israel Deaconess Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MUST device in people with Breast Cancer Screening, run by Transonic Imaging, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tejas Mehta, MD (617-667-2506, tmehta@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with true positive (malignant) breast lesions confirmed by biopsy (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.