Advanced Ultrasound Signal Processing of Suspicious Breast Images
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Imaging.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Breast Cyst, Microcalcification. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Advanced Ultrasound Beamforming Methods for Breast Imaging
Overview
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
- Diagnostic test Imaging
Ultrasound imaging or ultrasound imaging with light (i.e., photoacoustic imaging)
Primary outcome measures
- Image quality [Time frame: baseline]
- Number of microcalcifications [Time frame: baseline]
- Binary visibility of microcalcifications [Time frame: baseline]
- Subjective ratings [Time frame: baseline]
- Distinction of mass contents: solid vs. fluid [Time frame: baseline]
- Distinction of mass contents: benign vs. malignant [Time frame: baseline]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Johns Hopkins Outpatient Center — Baltimore
Identifiers
NCT: NCT07206888 · IRB00127110