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

Primary Purpose

Breast Cancer Screening

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MUST device

About this trial

This is an interventional screening trial for Breast Cancer Screening focused on measuring tomography, ultrasound, mammogram, breast

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Beth Israel Deaconess Medical Center BreastCare CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Number of subjects with true positive (malignant) breast lesions confirmed by biopsy

Sensitivity of MUST plus mammography versus mammography alone

Number of subjects with false positive (benign) breast lesions confirmed by biopsy

Specificity of MUST plus mammography versus mammography alone

Secondary Outcome Measures

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

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

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

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

Listing of adverse events experienced by subjects

Evaluate the safety of the MUST device by evaluating the adverse event profile

Full Information

NCT ID

NCT04102722

First Posted

June 11, 2019

Last Updated

January 14, 2020

Sponsor

Transonic Imaging, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04102722

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 14, 2020 (Actual)

Primary Completion Date

November 2020 (Anticipated)

Study Completion Date

November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Transonic Imaging, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer Screening

Keywords

tomography, ultrasound, mammogram, breast

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

All enrolled subjects will receive breast cancer screening with mammography and MUST

Masking

None (Open Label)

Allocation

N/A

Enrollment

1333 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single Arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

MUST device

Intervention Description

Imaging with MUST device

Primary Outcome Measure Information:

Title

Number of subjects with true positive (malignant) breast lesions confirmed by biopsy

Description

Sensitivity of MUST plus mammography versus mammography alone

Time Frame

14 days

Title

Number of subjects with false positive (benign) breast lesions confirmed by biopsy

Description

Specificity of MUST plus mammography versus mammography alone

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Number of true positive and false positive breast lesions categorized by BI-RADS breast density category as determined by the screening mammogram

Description

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

Time Frame

14 days

Title

For subjects who undergo biopsy, comparison of MUST results with biopsy results

Description

In the subpopulation of subjects who undergo biopsy, the concordance of MUST with biopsy will be estimated

Time Frame

60 days

Title

Description

Time Frame

60 days

Title

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.

Description

Time Frame

12 months

Title

Listing of adverse events experienced by subjects

Description

Evaluate the safety of the MUST device by evaluating the adverse event profile

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tejas Mehta, MD

Phone

617-667-2506

tmehta@bidmc.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tejas Mehta, MD

Organizational Affiliation

Beth Israel Deaconess Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Israel Deaconess Medical Center BreastCare Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tejas Mehta, MD, MPH

tmehta@bidmc.harvard.edu

First Name & Middle Initial & Last Name & Degree

Tejas Mehta, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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