Wearable Ultrasound Patch for Breast Imaging

Official title

Exploring the Application of a Wearable Ultrasound (US) Patch Device for Breast Imaging

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.

Detailed 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 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.

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.

Primary outcome measures

• Sensitivity and Specificity of the Wearable Ultrasound Patch for Detecting Breast Lesions [Time frame: From enrollment to 1 week after initial imaging]

Secondary outcome measures (1)

• Safety of the Wearable Ultrasound Patch [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.]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 1 center

• Massachusetts General Hospital — Boston

Publications

• 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
• 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

Identifiers

NCT: NCT07186491 · 25400

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗