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

Not Applicable

• Conditions: Breast Cancer Screening
• Interventions: Device: MUST device

• Registration Number: NCT04102722
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-25
• Status Verified: 2020-01
• Study Start: 2020-01-14
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18
• Primary Completion: 2020-11
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1333

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	MUST device	All enrolled subjects will undergo breast cancer screening with mammography and the MUST device

Primary Outcome Measures

Name	Time	Method
Number of subjects with false positive (benign) breast lesions confirmed by biopsy	14 days	Specificity of MUST plus mammography versus mammography alone
Number of subjects with true positive (malignant) breast lesions confirmed by biopsy	14 days	Sensitivity of MUST plus mammography versus mammography alone

Secondary Outcome Measures

Name	Time	Method
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	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
Listing of adverse events experienced by subjects	6 months	Evaluate the safety of the MUST device by evaluating the adverse event profile
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.	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
Number of true positive and false positive breast lesions categorized by BI-RADS breast density category as determined by the screening mammogram	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
For subjects who undergo biopsy, comparison of MUST results with biopsy results	60 days	In the subpopulation of subjects who undergo biopsy, the concordance of MUST with biopsy will be estimated

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center BreastCare Center; 🇺🇸 Boston, Massachusetts, United States