Breast CancerAUSPICIOUSNCT07206888
Advanced Ultrasound Signal Processing of Suspicious Breast Images
An observational study of Breast Cancer and Breast Cyst, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study aims to investigate recent developments in ultrasound signal processing to determine if these new techniques can enhance the visibility of important features of interest in breast ultrasound images. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Breast Cyst, Microcalcification
- What is being tested?
- Imaging
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2017to 1 Jan 2037
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Johns Hopkins Hospital
Who may be able to join
- Female adults (age >18 years) with at least one of the following:
- Macrocalcification(s) detected in x-ray 2D or 3D mammography images
- Macrocalcification(s) located next to cyst (or other identifiable landmark on an ultrasound image)
- A cyst, mass, or finding detected in diagnostic/screening ultrasound or mammography
Who cannot join
- (when performing ultrasound imaging only)
- Children (age < 18 years) are excluded
- (when performing ultrasound imaging with light, i.e., optoacoustic imaging)
- Children (age < 18 years) are excluded
- Is pregnant
- Has open sores including insect bites, rash, poison ivy, and chafing on the skin of the ipsilateral breast
Show all 9Show fewer
- Is experiencing phototoxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfonamides, ampicillin, tetracycline
- Is currently undergoing phototherapy
- Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or is undergoing treatment for a photosensitive disease and is experiencing photosensitivity
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
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21209
About this study
Official title: Advanced Ultrasound Beamforming Methods for Breast Imaging
This study aims to investigate recent developments in ultrasound signal processing to determine if these new techniques can enhance the visibility of important features of interest in breast ultrasound images. Ultrasound signals obtained from both standard ultrasound imaging and ultrasound imaging combined with light (also known as photoacoustic imaging) will be investigated.
- Conditions
- Breast Cancer, Breast Cyst, Microcalcification
- Being tested
- Imaging
- Keywords
- cyst, mass, diagnostic screening, ultrasound, mammography
- Medical subject headings
- Breast Neoplasms, Breast Cyst, Calcinosis, Cysts, Arachnodactyly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingDiagnostic test
Ultrasound imaging or ultrasound imaging with light (i.e., photoacoustic imaging)
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality
compare advanced beamforming and benchmark against a conventional beamforming technique by measuring and comparing standard image quality metrics
Measured: baseline
Number of microcalcifications
Measured: baseline
Binary visibility of microcalcifications
Clinicians (members of study team) will be shown images and record 'yes' if microcalcifications are present and 'no' if not.
Measured: baseline
Subjective ratings
Clinicians (members of study team) will be shown images and asked to provide subjective ratings of the images
Measured: baseline
Distinction of mass contents: solid vs. fluid
After examining the coherence measurements obtained from advanced beamforming techniques, the investigators will determine the ability of this quantitative information to distinguish between solid and fluid-filled masses
Measured: baseline
Distinction of mass contents: benign vs. malignant
After examining the coherence measurements obtained from advanced beamforming techniques, the investigators will determine the ability of this quantitative information to distinguish between solid malignant masses vs. solid benign masses
Measured: baseline
Secondary outcomes (4)
Number of true positives
The number of positive results that are correct
Measured: baseline
Number of false positives
The number of positive results that are incorrect
Measured: baseline
Number of true negatives
The number of negative results that are correct
Measured: baseline
Number of false negatives
The number of negative results that are incorrect
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start25 Apr 2017
- Primary completion1 Jan 2037 (estimated)
- Study completion1 Jan 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muyinatu Bell, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206888
- Sponsor's protocol ID
- IRB00127110
- Acronym
- AUSPICIOUS
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Ultrasound Beamforming Methods for Breast Imaging
- ClinicalTrials.gov ID
- NCT07206888
- Acronym / sponsor ID
- AUSPICIOUS / IRB00127110
- Conditions
- Breast Cancer, Breast Cyst, Microcalcification
- Keywords
- cyst, mass, diagnostic screening, ultrasound, mammography
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 1 Jan 2037 (estimated)
- Study completion
- 1 Jan 2037 (estimated)
- First posted
- 3 Oct 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.
This study aims to investigate recent developments in ultrasound signal processing to determine if these new techniques can enhance the visibility of important features of interest in breast ultrasound images. Ultrasound signals obtained from both standard ultrasound imaging and ultrasound imaging combined with light (also known as photoacoustic imaging) will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Johns Hopkins Hospital
Key inclusion criteria (4 listed)
- Female adults (age >18 years) with at least one of the following:
- Macrocalcification(s) detected in x-ray 2D or 3D mammography images
- Macrocalcification(s) located next to cyst (or other identifiable landmark on an ultrasound image)
- A cyst, mass, or finding detected in diagnostic/screening ultrasound or mammography
Key exclusion criteria (9 listed)
- (when performing ultrasound imaging only)
- Children (age < 18 years) are excluded
- (when performing ultrasound imaging with light, i.e., optoacoustic imaging)
- Children (age < 18 years) are excluded
- Is pregnant
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 |
|---|---|---|
| ImagingUltrasound imaging or ultrasound imaging with light (i.e., photoacoustic imaging) | Diagnostic test | – |
Primary outcome
Image quality
Time frame: baseline
compare advanced beamforming and benchmark against a conventional beamforming technique by measuring and comparing standard image quality metrics
Number of microcalcifications
Time frame: baseline
Binary visibility of microcalcifications
Time frame: baseline
Clinicians (members of study team) will be shown images and record 'yes' if microcalcifications are present and 'no' if not.
Subjective ratings
Time frame: baseline
Clinicians (members of study team) will be shown images and asked to provide subjective ratings of the images
Distinction of mass contents: solid vs. fluid
Time frame: baseline
After examining the coherence measurements obtained from advanced beamforming techniques, the investigators will determine the ability of this quantitative information to distinguish between solid and fluid-filled masses
Distinction of mass contents: benign vs. malignant
Time frame: baseline
After examining the coherence measurements obtained from advanced beamforming techniques, the investigators will determine the ability of this quantitative information to distinguish between solid malignant masses vs. solid benign masses
4 secondary outcomes
Number of true positives
Time frame: baseline
Number of false positives
Time frame: baseline
Number of true negatives
Time frame: baseline
Number of false negatives
Time frame: baseline
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 29 Oct 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.
Muyinatu Bell, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Cyst, run by Johns Hopkins 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 4 inclusion and 9 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 29 Oct 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?
Image quality (time frame: baseline). The study lists 6 primary outcomes in all. 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 29 Oct 2026.