Exploring the Application of a Wearable Ultrasound (US) Patch Device for Breast Imaging
Massachusetts General Hospital
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.
Description
This study is designed to evaluate the performance, safety, and reliability of a newly developed conformable wearable ultrasound (US) patch for whole-breast imaging. The device is a flexible, skin-adherent transducer array that provides real-time, three-dimensional imaging of the breast. The primary goal of the study is to assess the diagnostic accuracy of the US-patch device in detecting breast lesions across a variety of breast shapes, sizes, and tissue densities, using conventional handheld ultrasound as the reference standard (ground truth). Investigators plan to enroll 50 patients over a…
Eligibility
- Age range
- 18–85 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 Exclusion Criteria: * Having significant health problems (such as chronic or acute cardiovascular diseases, skin diseases) physical and/or be…
Interventions
- DeviceWearable 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.
Location
- Massachusetts General HospitalBoston, Massachusetts