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

Breast Cancer Screening Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04102722
• Other study ID #: MUST-02-001
• Status: Recruiting
• Phase: N/A
• Start date: January 14, 2020
• Est. completion date: November 2021

Study information

• Verified date: January 2020
• Source: Transonic Imaging, Inc.
• Contact: Tejas Mehta, MD
• Phone: 617-667-2506
• Email: tmehta[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1333
• Est. completion date: November 2021
• Est. primary completion date: November 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Screening
• Breast Neoplasms

Intervention

Device:
• MUST device
Imaging with MUST device

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center BreastCare Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Transonic Imaging, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with true positive (malignant) breast lesions confirmed by biopsy	Sensitivity of MUST plus mammography versus mammography alone	14 days
Primary	Number of subjects with false positive (benign) breast lesions confirmed by biopsy	Specificity of MUST plus mammography versus mammography alone	14 days
Secondary	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	14 days
Secondary	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	60 days
Secondary	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	60 days
Secondary	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	12 months
Secondary	Listing of adverse events experienced by subjects	Evaluate the safety of the MUST device by evaluating the adverse event profile	6 months