Advanced Ultrasound Signal Processing of Suspicious Breast Images

N/AEnrolling By InvitationNCT07206888

Johns Hopkins University252 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

252

Conditions

Breast Cancer Breast Cyst Microcalcification

Interventions

ImagingDIAGNOSTIC_TEST

Ultrasound imaging or ultrasound imaging with light (i.e., photoacoustic imaging)

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins Outpatient Center

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Image quality

compare advanced beamforming and benchmark against a conventional beamforming technique by measuring and comparing standard image quality metrics

Time frame: baseline

Number of microcalcifications

Time frame: 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.

Time frame: baseline

Subjective ratings

Clinicians (members of study team) will be shown images and asked to provide subjective ratings of the images

Time frame: 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

Time frame: baseline

Distinction of mass contents: benign vs. malignant

Time frame: baseline

Secondary Outcomes

Number of true positives

The number of positive results that are correct

Time frame: baseline

Data from ClinicalTrials.gov

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