Breast MassNCT07471672
Spot Compression Ultrasound Compared to Traditional Breast Ultrasound
A study testing Targeted ultrasound in the grid in people with Breast Mass, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of targeted breast ultrasound ("ultrasound in the grid") performed concurrently with diagnostic mammogram during breast compression with an open mammogram paddle in lesion detection when compared to standard diagnostic breast ultrasound. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Breast Mass
- What is being tested?
- Targeted ultrasound in the grid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to 1 Dec 2026
- 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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mass visible on both diagnostic mammogram and ultrasound
- Mass within the size limit to be completely confined within an open grid mammogram paddle (less than 3 cm)
Who cannot join
- None
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
Duke University Cancer Center
Durham, North Carolina, 27710
About this study
Official title: Efficacy of Spot Compression Ultrasound Compared to Traditional Breast Ultrasound
The purpose of this study is to determine the efficacy of targeted breast ultrasound ("ultrasound in the grid") performed concurrently with diagnostic mammogram during breast compression with an open mammogram paddle in lesion detection when compared to standard diagnostic breast ultrasound. Open paddle spot tomosynthesis and ultrasound in the grid images will be compared to the standard of care, and outcome measures will include comparing accuracy of lesion detection with the new technique versus the standard of care and differences in time to acquire the images for the new technique versus the current standard of care. Radiologists will also review the different sets of images and give confidence scores of lesion correspondence between mammogram and ultrasound. This will be a pilot study of 25 patients to demonstrate proof of concept and is intended to lay the foundation for future funded research with a larger patient population.
- Conditions
- Breast Mass
- Being tested
- Targeted ultrasound in the grid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted ultrasound in the gridDiagnostic test
Also called Spot tomosynthesis mammogram
Patients will have a single spot tomosynthesis mammogram image performed with an open compression paddle and concurrent targeted ultrasound imaging of the breast tissue contained in the open mammogram paddle while the breast is in compression.
| Study group | Role | What they receive |
|---|---|---|
| Spot Compression Ultrasound | Experimental | This arm includes all participants enrolled in the study who will receive the experimental imaging technique Receives: Diagnostic Test: Targeted ultrasound in the grid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of breast masses detected
The primary outcome will be whether breast masses can be detected using an open mammogram spot tomosynthesis compression paddle and targeted ultrasound in the grid using the experimental technique.
Measured: Single visit, up to approximately one hour
Secondary outcomes (1)
Time to acquire images
The total amount of time to acquire the experimental images (spot tomosynthesis mammogram view with open paddle and targeted ultrasound of breast tissue within the open compression grid).
Measured: Single visit, up to approximately one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study startSep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast MassStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eun L Langman, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471672
- Sponsor's protocol ID
- Pro00111770
- Status last verified
- Sep 2026
- First submitted
- 10 Mar 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Spot Compression Ultrasound Compared to Traditional Breast Ultrasound
- ClinicalTrials.gov ID
- NCT07471672
- Acronym / sponsor ID
- Pro00111770
- Conditions
- Breast Mass
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Mar 2026 (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 purpose of this study is to determine the efficacy of targeted breast ultrasound ("ultrasound in the grid") performed concurrently with diagnostic mammogram during breast compression with an open mammogram paddle in lesion detection when compared to standard diagnostic breast ultrasound. Open paddle spot tomosynthesis and ultrasound in the grid images will be compared to the standard of care, and outcome measures will include comparing accuracy of lesion detection with the new technique versus the standard of care and differences in time to acquire the images for the new technique versus the current standard of care. Radiologists will also review the different sets of images and give confidence scores of lesion correspondence between mammogram and ultrasound. This will be a pilot study of 25 patients to demonstrate proof of concept and is intended to lay the foundation for future funded research with a larger patient population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spot Compression Ultrasound | Experimental | Diagnostic Test: Targeted ultrasound in the gridThis arm includes all participants enrolled in the study who will receive the experimental imaging technique |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mass visible on both diagnostic mammogram and ultrasound
- Mass within the size limit to be completely confined within an open grid mammogram paddle (less than 3 cm)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Targeted ultrasound in the gridAlso: Spot tomosynthesis mammogramPatients will have a single spot tomosynthesis mammogram image performed with an open compression paddle and concurrent targeted ultrasound imaging of the breast tissue contained in the open mammogram paddle while the breast is in compression. | Diagnostic test | Spot Compression Ultrasound |
Primary outcome
Number of breast masses detected
Time frame: Single visit, up to approximately one hour
The primary outcome will be whether breast masses can be detected using an open mammogram spot tomosynthesis compression paddle and targeted ultrasound in the grid using the experimental technique.
1 secondary outcome
Time to acquire images
Time frame: Single visit, up to approximately one hour
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 15 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Eun L Langman, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted ultrasound in the grid in people with Breast Mass, run by Duke University 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 2 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 15 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of breast masses detected (time frame: Single visit, up to approximately one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2026.