Breast CancerNCT07186491
Wearable Ultrasound Patch for Breast Imaging
A study testing Wearable Ultrasound Patch in people with Breast Cancer and Breast Abnormalities, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Breast Abnormalities, Breast Lesion
- What is being tested?
- Wearable Ultrasound Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
Tolga Ozmen, M.D., 617-643-4398, tozmen@mgh.harvard.edu
About this study
Official title: Exploring the Application of a Wearable Ultrasound (US) Patch Device for Breast Imaging
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?
Read more
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.
Read the 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.
- Conditions
- Breast Cancer, Breast Abnormalities, Breast Lesion, Breast Asymmetry
- Being tested
- Wearable Ultrasound Patch
- Keywords
- Breast Imaging, Breast Cancer, Wearable Imaging, Breast Lesion, Ultrasound
- Medical subject headings
- Breast Neoplasms, Anisomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Breast Imaging with Wearable Ultrasound Device | Experimental | 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. Receives: Device: Wearable Ultrasound Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 1 week after initial imaging
Secondary 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.
Measured: From enrollment to 1 week after the initial US-patch imaging, and at any follow-up visit within the 12-month study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Responsible party
- Principal investigator, Tolga Ozmen, MD, Massachusetts General Hospital
- Investigators
- Tolga Ozmen, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186491
- Sponsor's protocol ID
- 25400
- Status last verified
- Jul 2026
- First submitted
- 15 Sep 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 39567702Du 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.
PubMed 37506210
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Application of a Wearable Ultrasound (US) Patch Device for Breast Imaging
- ClinicalTrials.gov ID
- NCT07186491
- Acronym / sponsor ID
- 25400
- Conditions
- Breast Cancer, Breast Abnormalities, Breast Lesion, Breast Asymmetry
- Keywords
- Breast Imaging, Breast Cancer, Wearable Imaging, Breast Lesion, Ultrasound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Imaging with Wearable Ultrasound Device | Experimental | Device: Wearable Ultrasound PatchParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Ultrasound PatchThe 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. | Device | Breast Imaging with Wearable Ultrasound Device |
Primary outcome
Sensitivity and Specificity of the Wearable Ultrasound Patch for Detecting Breast Lesions
Time frame: From enrollment to 1 week after initial imaging
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Background: PubMed 39567702Zhou 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.
- Background: PubMed 37506210Du 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tolga Ozmen, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Ultrasound Patch in people with Breast Cancer and Breast Abnormalities, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tolga Ozmen, M.D. (617-643-4398, tozmen@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of the Wearable Ultrasound Patch for Detecting Breast Lesions (time frame: From enrollment to 1 week after initial imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07186491, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.