Wearable Ultrasound Patch for Breast Imaging

NCT07186491 | Not Yet Recruiting

• 1 other identifier: 25400
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a wearable ultrasound (US) patch can provide reliable whole-breast imaging and accurately detect breast lesions in patients undergoing breast health evaluation. The main questions it aims to answer are:

• How well does the US-patch detect breast lesions in breasts of different shapes, sizes, and tissue densities?
• Are there any side effects or discomfort from using the US-patch? Researchers will compare results from the wearable US-patch to conventional ultrasound to see if the patch provides specific and sensitive findings. Participants will:
• Have breast imaging performed with the wearable US-patch, which is applied directly to the breast and secured with a sports bra.
• Use a guiding software application that helps correctly position the patch.
• Complete the imaging session in less than 15 minutes, performed by study personnel.

Conditions

Breast Cancer; Breast Abnormalities; Breast Lesion; Breast Asymmetry

Keywords

Breast Imaging; Breast Cancer; Wearable Imaging; Breast Lesion; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of the Wearable Ultrasound Patch for Detecting Breast Lesions

  The primary outcome will assess the diagnostic accuracy of the conformable US-patch device by comparing its breast lesion detection results to conventional handheld ultrasound (reference standard). Sensitivity and specificity will be calculated per lesion using true positive, false positive, true negative, and false negative determinations based on radiologist interpretation. This metric will serve as the main assessment of the device's performance in detecting breast anomalies across a range of breast shapes, sizes, and tissue densities.

  From enrollment to 1 week after initial imaging

Secondary Outcomes (1)

• Safety of the Wearable Ultrasound Patch

  From enrollment to 1 week after the initial US-patch imaging, and at any follow-up visit within the 12-month study period.

Study Arms (1)

Breast Imaging with Wearable Ultrasound Device

EXPERIMENTAL

Participants in this arm will undergo breast imaging using the wearable ultrasound (US) patch device. The patch is a flexible, skin-adherent transducer array designed to provide whole-breast 3D ultrasound imaging. It will be applied directly to the breast with coupling gel and secured with a sports bra to maintain contact. Imaging will be completed in less than 15 minutes, and results will be compared with conventional ultrasound, which serves as the reference standard.

Device: Wearable Ultrasound Patch

Interventions

Wearable Ultrasound Patch DEVICE

The Wearable Ultrasound Patch is a non-invasive imaging device designed to provide real-time breast imaging (3D) through a flexible, skin-adherent US transducer array. The patch conforms to the natural shape of the breast and allows for continuous and comfortable imaging, reducing patient discomfort and improving diagnostic efficiency. It is intended for use as an adjunct imaging tool for breast health assessment, enabling early detection and follow up of lesions in diverse breast morphologies. Patients will use a newly developed software application named "myFUS" to properly position the US probe on their body. The software application will prompt patients through all the required steps to complete the screening. The first imaging session will be performed by the study personnel with the help of the myFUS application.

Breast Imaging with Wearable Ultrasound Device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Investigators will exclusively enroll patients who have undergone conventional US imaging for their breasts within the past month or are scheduled to undergo it within the upcoming month.
• Patients with a history of breast cancer or prior breast surgery can also be enrolled
• Female gender
• Ages between 18 and 85 years old
• Being able to understand, communicate, give valid consent to the study, and be understood by researchers

You may not qualify if:

• Having significant health problems (such as chronic or acute cardiovascular diseases, skin diseases) physical and/or behavioral health disabilities limiting participants' ability to follow directions and complete research related activities.
• Being pregnant
• Not having intact, healthy breast skin (having open scars or wounds around the location of the breast)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Massachusetts Institute of Technology: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• Zhou S, Park G, Longardner K, Lin M, Qi B, Yang X, Gao X, Huang H, Chen X, Bian Y, Hu H, Wu RS, Yue W, Li M, Lu C, Wang R, Qin S, Tasali E, Karrison T, Thomas I, Smarr B, Kistler EB, Khiami BA, Litvan I, Xu S. Clinical validation of a wearable ultrasound sensor of blood pressure. Nat Biomed Eng. 2025 Jun;9(6):865-881. doi: 10.1038/s41551-024-01279-3. Epub 2024 Nov 20.

  PMID: 39567702 BACKGROUND

• Du W, Zhang L, Suh E, Lin D, Marcus C, Ozkan L, Ahuja A, Fernandez S, Shuvo II, Sadat D, Liu W, Li F, Chandrakasan AP, Ozmen T, Dagdeviren C. Conformable ultrasound breast patch for deep tissue scanning and imaging. Sci Adv. 2023 Jul 28;9(30):eadh5325. doi: 10.1126/sciadv.adh5325. Epub 2023 Jul 28.

  PMID: 37506210 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Anisomastia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tolga Ozmen, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tolga Ozmen, M.D.

CONTACT

617-643-4398; tozmen@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Breast Surgery, Surgical Oncology

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The results should be made public within 24 months of reaching the end of the study. The study's end is the time point at which the last data items are to be reported, or after the outcome data are mature for analysis.
• Access Criteria: Only members of the MIT-MGB research team will have access to the IPD.

Locations

US (1)