ClinicalTrials.gov record NCT07206888
Advanced Ultrasound Signal Processing of Suspicious Breast Images
Advanced Ultrasound Beamforming Methods for Breast Imaging
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This observational study collects ultrasound images (standard ultrasound and ultrasound with light/photoacoustic imaging) from adult women with suspicious breast findings such as masses, cysts, or calcifications. It compares advanced beamforming image processing with conventional processing to measure image quality and how clearly important features appear. Clinicians on the study team will review and rate images while researchers analyze quantitative image metrics.
What it is studying. The study is testing whether new ultrasound signal-processing methods (advanced beamforming), using standard ultrasound and ultrasound with light (photoacoustic), produce image data that change measurable image quality and clinicians' ability to see features such as microcalcifications and whether quantitative measures can help tell solid from fluid masses and benign from malignant solid masses.
What the researchers hope to learn. To measure and compare image quality metrics from advanced beamforming versus conventional beamforming; to record clinicians' visibility and subjective ratings of microcalcifications and other features; to assess whether coherence or other quantitative measures can distinguish solid versus fluid masses and benign versus malignant solid masses; and to report counts of true/false positives and negatives for the imaging comparisons.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Diagnostic test
- Imaging
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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
Exclusion criteria
- (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
- 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
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
You would have breast ultrasound scans—either standard ultrasound or ultrasound combined with light (optoacoustic/photoacoustic imaging). Before any light-based imaging, staff will screen for pregnancy, skin sores on the same breast, recent photosensitizing drugs, current phototherapy, or photosensitive diseases; those findings make you ineligible for the light-based imaging. Study clinicians will review and rate the images. The registry does not list additional invasive procedures.
How the study is structured. Observational, cross-sectional cohort study. Participants undergo imaging (standard ultrasound or ultrasound with light/photoacoustic imaging) at a single time point; images are processed with advanced beamforming and with a conventional method. Study clinicians view and rate the images and investigators compute objective image-quality and diagnostic metrics for comparison.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Breast Cancer; Breast Cyst; Microcalcification. Does it apply to my diagnosis?
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says participants are enrolled by invitation. Who decides who is invited, and how?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
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Important dates
- Study start
- Apr 25, 2017
- Primary completion
- Jan 1, 2037 (estimated)
- Study completion
- Jan 1, 2037 (estimated)
- Target enrollment
- 252 participants (estimated)
- Last updated on registry
- Oct 14, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Johns Hopkins University
Participating sites (1)
- Johns Hopkins Outpatient Center
Baltimore, Maryland, 21209 · United States
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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