Wearable Ultrasound Patch for Breast Imaging

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

Interventions

DEVICE

Wearable Ultrasound Patch

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.

Sponsors & Collaborators

• Massachusetts Institute of Technology

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Tolga Ozmen, M.D. · Massachusetts General Hospital

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2026-12-31

Completion

2027-03-31

Countries

• United States

Study Locations