An interventional study of Wearable Ultrasound Patch in Breast Cancer, Breast Abnormalities and Breast Lesion, sponsored by Massachusetts General Hospital. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Diagnostic
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:
Researchers will compare results from the wearable US-patch to conventional ultrasound to see if the patch provides specific and sensitive findings.
Participants will:
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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
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.
Plan to share: Yes — De-identified participant data will be shared with other researchers for scientific and educational purposes. This may include imaging data from the wearable US-patch device, conventional ultrasound results, and associated clinical and demographic information. No personal identifiers (such as names, contact information, or dates of birth) will be included. Data will be shared under a formal data use agreement to ensure confidentiality and proper use.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital