Wearable Ultrasound Patch for Breast Imaging

N/ANot Yet RecruitingNCT07186491

Massachusetts General Hospital50 enrolled

Overview

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.

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 12-month period who are undergoing breast health evaluation and either have had or are scheduled for conventional breast ultrasound within one month. Participants will undergo imaging with the US-patch device, which will be applied directly to the breast and secured with a sports bra to maintain consistent contact. The imaging session will take less than 15 minutes and will be performed by trained study personnel. The diagnostic performance of the US-patch device will be assessed by calculating sensitivity and specificity for breast lesion detection, using true positive, false positive, true negative, and false negative determinations based on radiologist interpretation. Statistical analyses will be performed on a per-lesion basis. Findings will be compared to conventional ultrasound results to determine the accuracy and reliability of the device. Safety and tolerability will also be evaluated. All participants will be contacted by telephone one week after the imaging session to assess for any delayed adverse effects. Participants who return for follow-up visits within the one-year study period will undergo repeat US-patch imaging, and any adverse events, discomfort, or skin irritation will be documented.

Study Type

Interventions

Wearable Ultrasound PatchDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 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)

Outcomes

Primary Outcomes

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.

Time frame: From enrollment to 1 week after initial imaging

Secondary Outcomes

Safety of the Wearable Ultrasound Patch

The number of participants experiencing adverse effects, discomfort, or skin irritation related to the wearable US-patch device will be recorded. Participants will be contacted by telephone one week after the initial imaging session, and any follow-up imaging visits within the one year study period will also include assessment of safety and tolerability.

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