Wearable Ultrasound Patch for Breast Imaging
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-85
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Wearable Ultrasound Patch
DeviceThe 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Breast Imaging with Wearable Ultrasound DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 imagingSecondary outcomes
1
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Massachusetts Institute of Technology
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: